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Halted Progression of Soft Palate Cancer in a Patient Treated with the Paleolithic Ketogenic Diet Alone: A 20-months Follow-up

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  • International Center for Medical Nutritional Intervention

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Introduction: Myoepithelial tumor of the soft palate is associated with rapid progression and poor outcome. The standard care includes surgery with optional radiotherapy and/or chemotherapy. Case report: Here we present a case with myoepithelial tumor of the soft palate where the patient denied conventional treatment options. Instead, the patient started the paleolithic ketogenic diet which resulted in a halted progression of the tumor as evidenced by imaging follow-up. Currently, the patient is on the diet for 20 months, without symptoms and side effects. Conclusion: We conclude that the paleolithic ketogenic diet was effective and safe in this patient.
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American Journal of Medical Case Reports, 2016, Vol. 4, No. 8, 288-292
Available online at http://pubs.sciepub.com/ajmcr/4/8/8
©Science and Education Publishing
DOI:10.12691/ajmcr-4-8-8
Halted Progression of Soft Palate Cancer in a Patient
Treated with the Paleolithic Ketogenic Diet Alone:
A 20-months Follow-up
Csaba Tóth1, Zsófia Clemens1,2,*
1Paleomedicina Hungary Ltd, Evolutionary Medicine Working Group, Budapest, Hungary, H-1026 Hidász u. 3/A, Budapest, Hungary
2University of Pécs, Department of Neurology, Pécs, Hungary, H-7623 Rét u. 2, Pécs, Hungary
*Corresponding author: clemenszsofia@gmail.com
Abstract Introduction: Myoepithelial tumor of the soft palate is associated with rapid progression and poor
outcome. The standard care includes surgery with optional radiotherapy and/or chemotherapy. Case report: Here we
present a case with myoepithelial tumor of the soft palate where the patient denied conventional treatment options.
Instead, the patient started the paleolithic ketogenic diet which resulted in a halted progression of the tumor as
evidenced by imaging follow-up. Currently, the patient is on the diet for 20 months, without symptoms and side
effects. Conclusion: We conclude that the paleolithic ketogenic diet was effective and safe in this patient.
Keywords: soft palate tumor, myoepithelial tumor, paleolithic diet, ketogenic diet
Cite This Article: Csaba Tóth, and Zsófia Clemens, Halted Progression of Soft Palate Cancer in a Patient
Treated with the Paleolithic Ketogenic Diet Alone: A 20-months Follow-up.” American Journal of Medical Case
Reports, vol. 4, no. 8 (2016): 288-292. doi: 10.12691/ajmcr-4-8-8.
1. Introduction
Otto Warburg was the first to suggest that cancer
emerges from abnormal cellular metabolism [1]. He
postulated that key points in tumorigenesis include
impaired oxidative phosphorilation, compensatory
glycolysis and aerobic fermentation [1]. Utilization of fat
for energy ultimately relies on the mitochondria and the
associated metabolic pathways. Tumor cells, with
dysfunctional mitochondria are unable to use ketones but
largely depend on glucose for energy [2,3]. Based on this,
adopting a ketogenic diet, which represent a shift from
carbohydrates toward fat, has been repeatedly suggested
as a promising option to treat cancer [3,4].
Encouraging studies in cancer patients with the
ketogenic diet include a landmark study from 1995
reporting long-term survival in two children with brain
tumor [5] and another case report which reported halted
progression of glioblastoma for a few months [6]. In
recent years several group studies have been carried out
using the ketogenic diet in cancer. Overall, these studies
did confirm that the ketogenic diet is relatively safe [7,8]
and may diminish side effects associated with
chemotherapy and/or radiotherapy [9]. However, as
regards hard clinical endpoints, such as survival, no clear
evidence is coming from these group studies supporting
that the ketogenic diet is indeed beneficial. In the study of
Schmidt et al. [7] and that of Fine et al. [10] advanced
cancer patients were put on the ketogenic diet. In both
studies [7,10] there was a tendency for halted disease
progression in those patients adhering to the diet.
However both studies were limited in follow-up duration
with three and one months. In the ERGO study recurrent
glioblastoma patients were put on the ketogenic diet but
all patients progressed while on the diet [8]. In a
retrospective study of Champ et al. [11] six glioblastoma
patients were on the ketogenic diet for 3-12 months.
Survival benefit was uncertain, however, one patient
showed no signs of recurrence at 12 months of diet
therapy. In patiens with tuberous sclerosis tumor
progression was not halted by the ketogenic diet [12]. In
the most recent study the ketogenic diet resulted in tumor
regression in those patients with early stage cancer [13].
This study was however limited in duration too.
An assessement of the available patient studies shows
that there are two features common to all of them. First,
the dietary therapy was used following and/or
concurrently with radiation and/or chemotherapy. Second,
all studies used the classical version of the ketogenic diet
which is based on vegetable oils and/or also included
dairy, formula feeding or supplements.
Ketosis is often viewed as an evolutionary adapted state
in humans [14]. In their study Schmidt et al. [7] also cite
Steffanson who studied and proposed the traditional diet
of the Inuit which is actually an animal meat-fat diet [15].
The most comprehensive overview on the animal meat-fat
diet is provided by gastroenterologist Voegtlin [16], who
is rarely cited in the context of the ketogenic diets.
Considering ketosis as evolutionary adapted state
combined with the knowledge on the diet of ancestral
people [17], we propose that an ideal therepeautic diet in
cancer would also rely on animal fat instead of vegetable-
based oils used in previous clinical trials.
Accordingly, the authors of the present study are using
a diet based on animal meat and fat, similar to that
American Journal of Medical Case Reports 289
proposed by Steffanson [15] as well as Voegtlin [16]. In
an attempt to distinguish this diet from both the classical
ketogenic as well as the diet termed paleolithic in a series
of clinical studies [18] and books [17], we refer the diet as
paleolithic ketogenic. Previously we have published cases
of type 1 [19,20], type 2 diabetes [21], epilepsy [22,23],
Gilbert’s syndrome [24] and Crohn’s disease [25] where
we successfully applied the diet. Here we present a case
with soft palate tumor of myoepithelial origin, an
aggressive cancer type, where using the paleolithic
ketogenic diet without any conventional treatment
modalities resulted in halted progression of the tumor for
20 months, while producing no symptoms or side effects.
2. Case Report
The 60-year-old patient was non-smoker and denied
alcohol consumption. For the six months before diagnosis
she had been feeling a lump in her soft palate which was
asymptomatic and did neither cause airway obstruction
nor dysphagia. The mass was firm and without ulceration.
Biopsy was taken on on 31 Oct 2014 and histopathology
showed myoepithelial carcinoma (Grade 2 tumor). The
MRI on 20 Dec 2014 showed a well-circumscribed and
non-infiltrative mass measuring 36x33x27 mm arising
from the left soft palate. The tumor was staged as
T2,N0,M0. Knowing the malignicity of such tumors, the
patient was offered radical surgery and palatal lift
prosthesis which she did not accept. The patient did
neither received chemotherapy nor radiotherapy.
3. Paleolithic Ketogenic Diet
We first met the patient in December 2014, shortly after
diagnosis onset. We recommended the paleolithic
ketogenic diet which the patient started instantly. The
paleolithic ketogenic diet is an animal meat-fat based diet
with a fat:protein ratio of approximately 2:1 and with a
plant content less than 30% (in volume). In the diet,
consumption of red and fat meats over lean meats as well
as organ meats are encouraged. In the first six months the
patient followed the most strict form of the diet: a full
meat-fat diet. From July 2015 on, she was allowed to eat
small amounts of vegetables with a frequency of ≤2 times
a week. From this time on she was also allowed to drink
coffee in moderation as well as to use small amounts of
honey for sweetening. No calorie restriction was applied
but the patient was suggested to eat when hungry and then
to eat until satiation. Typically the patient had two meals a
day. The patient regularly used urinary ketone strips
which indicated sustained ketosis. Altogether, the patient
exhibited a high level of dietary compliance as assessed
by laboratory parameters (Table 1) and patient feedback.
The patient was followed by personal visits every three
months. In between she was followed by e-mail and phone
calls. At the time of writing the manuscript the patient is
on the diet for 20 months.
Table 1. Laboratory measurements during follow-up ont he paleolithic ketogenic diet
17.04.
2015
25.09.
2015
30.10.
2015
25.11.
2015
26.02.
2016
17.06.
2016
21.07.
2016
normal range
WBC (G/l)
4.32
5.22
4.37
4.34
3.5
3.9
3.6
4-10
RBC (T/l)
4.32
4.47
4.31
4.58
4.48
4.65
4.55
4-5.6
Hgb (g/l)
126
129
126
130
130
135
132
120-160
Hct (%) 0.371 0.381 0.371 0.387 0.402 0.411 0.403 0.36-0.46
Thrombocyte (G/l)
232
217
244
230
192
213
211
120-350
CRP (mg/l)
-
1.4
1.9
2
1.6
2.9
1
< 5
ESR (mm/h) 14 14 26 25 18 27 25 1-30
Total protein (g/l)
-
71.7
66.7
67.2
65.7
71.5
70.4
66-83
Carbamid (mmol/l) 7.2 8.4 6.2 6.2 8.7 6.9 8.7 2.8-7.2
Creatinine (µmol/l)
51.5
50.1
40.1
45.8
40.6
44.7
44.1
45-84
Sodium (mmol/l)
137
140
139
140
141
138
138
136-146
Potassium (mmol/l) 3.7 3.9 3.7 4.2 3.5 4 4 3.5-5.1
LDH (U/l)
-
246
230
249
259
245
253
208-378
GOT (U/l) 18 15 15 17 16 19 18 < 31
GPT (U/l)
19
16
17
18
17
-
26
< 34
GGT (U/l)
14
15
13
13
13
13
14
< 38
ALP (U/l)
-
67
60
-
-
64
-
30-120
Iron (µmol/l)
11.6
11.2
10.3
11.8
11.3
13
12.4
10.7-32.2
Uric acid (µmol/l) 213 301 318 267 199 - 187 155-357
Glucose (mmol/l)
4.4
4.9
4.7
4.6
4.9
6
5.8
3.5-6
Calcium (mmol/l)
2.29
2.27
2.24
2.31
2.3
-
2.33
2.2-2.65
Magnesium (mmol/l) 0.85 0.83 0.81 0.84 0.81 0.79 0.85 0.77-1.03
T. chol. (mmol/l)
9.5
8.3
8.6
8.6
9.6
9.4
9.4
3.9-5.6
HDL chol. (mmol/l) 2.04 1.97 1.93 2.11 1.98 2.21 2.44 1.15-3
Triglyceride (mmol/l)
0.71
0.87
0.67
0.64
0.72
0.68
0.6
0.5-1.6
Fibrinogen (g/l)
-
-
4.7
4.5
3.5
4.7
4.1
2-4
Urinary ketones ++ ++ +++ ++ + ++ +
Abbreviations: WBC: white blood cell count, RBC: red blood cell count, Hgb: hemoglobin, Hct: hematocrit, CRP: C-reactive protein, ESR: erythrocyte
sedimentation rate, LDH: lactate dehydrogenase, GOT: glutamate-oxaloacetate transaminase, GPT: glutamate-pyruvate transaminase, GGT: gamma-
glutamyl transferase, ALP: alkaline phosphatase,
T. cholesterol: total cholesterol, HDL chol.: high density lipoprotein, LDL: low density lipoprotein. indicates that a given parameter was not measured.
290 American Journal of Medical Case Reports
4. Laboratory Data
Laboratory workup was performed seven times during
the follow-up which indicated a high level of dietary
adherence (Table 1). Glucose levels averaged 5 (±0.6)
mmol/l. Renal and liver function as well as ions were
normal. Inflammatory markers CRP and ESR (erythrocyte
sedimentation rate) were in the normal range while
fibrinogen was mildly elevated on some measurements.
Cholesterol was elevated while triglyceride was low.
Urinary ketone was positive on each workup.
Figure 1. Subsequent MRI scans showing the tumor in left soft palate. The first one (on 20 Dec 2014) was performed at diagnosis onset. The three
subsequent MRI were performed during follow-up on the paleolithic ketogenic diet
5. MRI Imaging
Three follow-up MRI examinations were carried out
which indicated a minor decrease in tumor size. The first
follow-up exam, on 18 Apr 2015, showed no change in
tumor size (36x33x27 mm) while the two subsequent MRI
examinations (on 28 Oct 2015 and 12 Jan 2016) showed a
decreased tumor size (33x27x24 mm). No enlarged lymps
nodes were seen on either MRI exams.
6. Condition and Symptoms
The patient was highly motivated and so it was
relatively easy for her to maintain the diet.
The patient reported no side effects of the diet but
improved physical fitness and well-being. Currently she is
on the diet for 20 months. Subjectively she feels that the
tumor diminished. At diet onset she weighted 68 kg and
was 165 cm tall (BMI=25). Currently she weights 63 kg
(BMI=23).
7. Patient Consent
Written informed consent was obtained from the patient
for publication of this case report.
8. Discussion
In animal models the ketogenic diet has been shown to
have antitumor effects [3]. In the human literature several
benefits have been associated with the ketogenic diet
including imrovement in quality of life [7] as well as a
decrease in therapy-induced side effects [9]. Yet, apart
from an early study from 1995 [5], no reports are available
on long-term survival benefit associated with the diet. The
ketogenic diet is generally proposed as an adjunct to
conventional treatments to enhance their effectivity. At the
same time, as also pointed out by Seyfried [26],
chemotherapy and radiation may induce necrosis and
inflammation both of which elevate extracellular
American Journal of Medical Case Reports 291
glutamate and glucose concentrations and thereby may
contribute to cancer progression. Cortocosteroids, which
are frequently administered along with radiation therapy,
also contribute to this process [26]. As a result,
conventional treatments may turn counterproductive and
may also conteract the beneficial effect of dietary
carbohydrate restriction [26]. As far as we know, our case
study is the first one in the literature where a ketogenic
diet is used as a stand-alone therapy in cancer. This study
is also the first in using a ketogenic diet based on animal
meat and fat instead of the classical version based on
vegetable oils and dairy. We assume that both factors
might have significantly contributed to the success
achieved in the present case.
Myoepithelial tumors are rare tumors accounting for
less than 1 % of all salivary gland tumors [27]. In this
tumor type surgery is the first choice of treatment with
optional postsurgical radiotherapy and/or chemotherapy
[28]. Myoepithelial tumors typically exhibit extensive
growth and infiltration to adjacent tissues [28]. Overall,
prognosis for myoepithelial tumors of the head and neck is
poor with the 3- and 5-years survival of 59% and 32%,
respectively [27]. Incomplete surgery is known to be
associated with an even worse outcome [27]. Halted
progression and the absence of tumor-associated
symptoms in our case represent a much better outcome
than could be expected based on the statistics of this tumor
type.
The patient showed excellent dietary adherence as also
shown by laboratory workups. Her laboratory parameters
are similar to that seen in our other patients on the paleolithic
ketogenic diet with other diseases [19,20,21,22,23,24,25].
We opine that, beyond maintaning ketosis, avoiding
vegetable oils, dairy as well as other non-paleolithic food
items all represent key factors in the successful
management of this case. As we showed in a previous
case study, the paleolithic ketogenic diet was also more
efficient in reducing symptoms as compared with the
popular version of the paleolithic diet [24]. Non-
paleolithic components (e.g. milk and dairy, grains) of the
classical ketogenic diet and that of the standard diet have
been suggested to increase pathological intestinal
permeability [17]. Accordingly, in our previous case study
on Crohn’s disease, we showed that pathological intestinal
permeability had normalized while on the paleolithic
ketogenic diet [25]. Such a normalizaton of intestinal
permeability was not seen in a study using a much more
popular and indulgent version of the paleolithic diet [29].
Importantly, increased permeability of the intestine and
that of other membranes was suggested to play a role in
the cancerous transformation of normal tissues [30]. In
addition, while the classical forms of the ketogenic diet
has been described to induce side effects including
diarrhea, constipation, deficiency of magnesium, iron and
other vitamins [31], the paleolithic ketogenic diet results
in no such side effects.
We assume that the paleolithic diet may be of superior
effectiveness while having no side effects as compared to
the classical ketogenic diet in cancer management. It is
our opinion that such a preferable effectivity/side effect
profile of the paleolithic ketogenic diet can only be
explained evolutionarily. We assume that the paleolitic
ketogenic diet is the evolutionary adapted diet itself for
humans.
Acknowledgement
The authors received no support from any organization.
Conflict of Interest
The authors declare no conflict of interest.
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... The PKD differs from the classical KD in that it excludes food components that are not available in preagricultural times, and it supplies optimal amounts of micronutrients (73). Toth et al. have proven that the PKD has a considerable effect on soft palate cancer, rectal cancer, glioblastoma multiforme, and cervical intraepithelial neoplasia (72)(73)(74)(75). The researchers assume that this diet is evolutionarily advantageous for humans and has superior effectiveness compared to the KD in cancer management (72,73). ...
... Toth et al. have proven that the PKD has a considerable effect on soft palate cancer, rectal cancer, glioblastoma multiforme, and cervical intraepithelial neoplasia (72)(73)(74)(75). The researchers assume that this diet is evolutionarily advantageous for humans and has superior effectiveness compared to the KD in cancer management (72,73). Thus, the PKD provides hopes for refractory cancer therapy and we do believe that further studies should be conducted to explore the possible mechanisms of PKD in the treatment of cancer and other chronic diseases. ...
... Although diet has been used to improve immunotherapy and enhance the efficacy of chemotherapy or RT, it is still regarded as a nutritional supplement. Toth et al. (72)(73)(74)(75) have pointed out that nonsurgical therapies might hinder the effects of metabolic therapies and might even lead to the tumor progression in several studies. Therefore, the consideration of using diet therapy as a stand-alone treatment may bring unexpected results. ...
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Studies in animal models have suggested that the ketogenic diet may be effective in the treatment of cancer. However, human cohort studies on the ketogenic diet have, thus far, failed to show benefits in cancer survival or in any other hard clinical endpoints of the disease. This paper presents a case report of a patient with glioblastoma multiforme. The patient had initially been treated with standard oncotherapy including surgery, radiotherapy and chemotherapy. Despite standard treatment, the patient experienced a recurrence of the glioblastoma seven months later. Subsequently, the patient refused radiotherapy and chemotherapy and opted to use the paleolithic ketogenic diet (PKD) as a stand-alone therapy. Following the adoption of the PKD, progression of the disease has been completely halted. At the time of writing, the patient has remained in remission for 38 months, is without side-effects and experiences an excellent quality of life without the use of any drugs.
... The primary search in PubMed resulted in 157 articles of which 13 were original research papers on tumor patients [14,[26][27][28][29][30][31][32][33][34][35][36][37], 32 on animals , two studies on both [70,71], and two were meta-analysis of animal studies [72,73]. Another seven animal studies [74][75][76][77][78][79][80] and nine human studies [81][82][83][84][85][86][87][88][89] were identified by the secondary search process. Subsequently, 14 animal studies were excluded because either they initiated the KD prior to tumor cell injection [43,45,68,69] or they had no control group [46] or they basically replicated the results of a previously published tumor model system ( [39,40,75] replicated [38], [76] replicated [44], [59] replicated [77], [61] replicated [53], [80] replicated [58], and [62,67] replicated [47,49]). ...
... Only one study using an extremely lowprotein KD with many artificial foods provided evidence for a detrimental effect [71]. Most frequent improvements concerned the general condition [26,27,36,84,85,87,88] and neurological function/seizure control in patients with brain tumors [14,28,34,89]. Side effects attributed to the KD were generally mild and reversible [86]. ...
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Background Ketogenic diets (KDs) have gained popularity among patients and researchers alike due to their putative anti-tumor mechanisms. However, the question remains which conclusions can be drawn from the available human data thus far concerning the safety and efficacy of KDs for cancer patients. Methods A realist review utilizing a matrix-analytical approach was conducted according the RAMEsEs publication standards. All available human studies were systematically analyzed and supplemented with results from animal studies. Evidence and confirmation were treated as separate concepts. Results 29 animal and 24 human studies were included in the analysis. The majority of animal studies (72%) yielded evidence for an anti-tumor effect of KDs. Evidential support for such effects in humans was weak and limited to individual cases, but a probabilistic argument shows that the available data strengthen the belief in the anti-tumor effect hypothesis at least for some individuals. Evidence for pro-tumor effects was lacking completely. Conclusions Feasibility of KDs for cancer patients has been shown in various contexts. The probability of achieving an anti-tumor effect seems greater than that of causing serious side effects when offering KDs to cancer patients. Future controlled trials would provide stronger evidence for or against the anti-tumor effect hypothesis.
... Considering the arguments advocating application of KD and the paleolithic diet, the researchers developed a dietary model that is known as the paleolithic ketogenic diet [83,84]. The paleolithic ketogenic diet was introduced in a 60 years old patient, diagnosed with epithelial-myoepithelial carcinoma of the parotid gland, who did not agree to conventional treatment. ...
... It can be concluded from the data that introduction of an alternative dietary model inhibited tumor growth. The patient continued the diet for 20 months [83]. ...
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The differences between the metabolism and the physiology of cancer cells and the cells of the human body are assessed and used in most anticancer treatments. These differences encompass, among others, increased glucose metabolism in the changed cells. The aim of the paper was to discuss the results of studies concerning the relationship between lowcarbohydrate diets and fasting and the course of cancer. An inappropriately composed diet consisting of high amounts of simple sugars supplies cancer cells with nutrients, which may impair the effectiveness of cancer patients treatment. Lowcarbohydrate diets may, therefore, constitute an element of supplementary therapy in cancer treatment. The mechanism of low-carbohydrate diets in combination with standard treatment has not been completely explained, though. In initial studies it was proven that patients who were able to continue low-carbohydrate diets showed improvement in health and reduction of tumor mass or its slower growth. Moreover, it was observed that the inability of cancer cells to adapt in new environmental conditions that occur while fasting may have toxic effect on them. Introduction of fasting may sensitize cancer cells to chemotherapy, decrease concentration of growth factors and lead to repair of normal cells. On the other hand, fasting may also promote autophagy and, as can be concluded from the literature, its mechanism may have twofold activity: as a process impacting the survival or death of cancer cells.
... Carbohydrates were strictly eliminated from the patient's diet. The patient recognized that a well-formulated animal-based Paleo-carnivore diet would provide most bioavailable micronutrients (78). This carnivore nutritional fasting schedule returned the patient's GKI values to 2.0 or below. ...
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Background: Successful treatment of glioblastoma (GBM) remains futile despite decades of intense research. GBM is similar to most other malignant cancers in requiring glucose and glutamine for growth, regardless of histological or genetic heterogeneity. Ketogenic metabolic therapy (KMT) is a non-toxic nutritional intervention for cancer management. We report the case of a 32-year-old man who presented in 2014 with seizures and a right frontal lobe tumor on MRI. The tumor cells were immunoreactive with antibodies to the IDH1 (R132H) mutation, P53 (patchy), MIB-1 index (4–6%), and absent ATRX protein expression. DNA analysis showed no evidence of methylation of the MGMT gene promoter. The presence of prominent microvascular proliferation and areas of necrosis were consistent with an IDH -mutant glioblastoma (WHO Grade 4). Methods: The patient refused standard of care (SOC) and steroid medication after initial diagnosis, but was knowledgeable and self-motivated enough to consume a low-carbohydrate ketogenic diet consisting mostly of saturated fats, minimal vegetables, and a variety of meats. The patient used the glucose ketone index calculator to maintain his Glucose Ketone Index (GKI) near 2.0 without body weight loss. Results: The tumor continued to grow slowly without expected vasogenic edema until 2017, when the patient opted for surgical debulking. The enhancing area, centered in the inferior frontal gyrus, was surgically excised. The pathology specimen confirmed IDH1- mutant GBM. Following surgery, the patient continued with a self-administered ketogenic diet to maintain low GKI values, indicative of therapeutic ketosis. At the time of this report (May 2021), the patient remains alive with a good quality of life, except for occasional seizures. MRI continues to show slow interval progression of the tumor. Conclusion: This is the first report of confirmed IDH1 -mutant GBM treated with KMT and surgical debulking without chemo- or radiotherapy. The long-term survival of this patient, now at 80 months, could be due in part to a therapeutic metabolic synergy between KMT and the IDH1 mutation that simultaneously target the glycolysis and glutaminolysis pathways that are essential for GBM growth. Further studies are needed to determine if this non-toxic therapeutic strategy could be effective in providing long-term management for other GBM patients with or without IDH mutations.
... Furthermore, Paleolithic eating patterns have been associated with gut microbial diversity [24] and reduction of sporadic colorectal adenoma incidence rates [25]. Several case reports by the Hungarian group led by Zsofia Clemens and Csaba Tóth have shown that a ketogenic version of a Paleolithic diet excluding all plant fats and focusing on "nose-to-tail" eating of animals may exert beneficial effects against different tumor entities [26][27][28][29]. However, to date, no clinical study has investigated a Paleolithic diet during oncological standard treatment. ...
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Evolutionary principles are rarely considered in clinical oncology. We here aimed to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting. A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a "Paleolithic lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching. A total of eleven patients completed the study. The majority of patients (64%) reported feeling good or very good during the intervention. The intervention group experienced an average decrease of 0.4 kg body weight (p < 0.001) and 0.34 kg (p < 0.001) fat mass per week, but fat-free and skeletal muscle mass were not significantly affected. Vitamin D levels increased slightly from 23.8 (11-37.3) ng/ml to 25.1 (22.6-41.6) ng/ml (p = 0.053). β-hydroxybutyrate levels were significantly increased and triglycerides and free T3 hormone levels significantly reduced by the PL intervention. This pilot study shows that adoption of a PL intervention during curative radiotherapy of breast cancer patients is feasible and able to reduce fat mass. Daily outdoor activity could eliminate vitamin D deficiency (vitamin D < 20 ng/ml). Future studies are needed to confirm these findings.
... A small trial in advanced cancer patients showed improvement in sleep and emotional function after a three-month KD intervention [12]. Other studies have suggested enhanced cognitive function [9,13]. ...
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Introduction: Despite recent interest in the use of ketogenic diets (KDs) for cancer, evidence of beneficial effects is lacking. This study examined the impact of a randomly assigned KD on quality of life, physical activity and biomarkers in patients with breast cancer. Method: A total of 80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes were randomly assigned to either a KD or a control group for this 12-week trial. Concurrent with the first, third, and fifth chemotherapy sessions, quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones) were assessed. Dietary intake was also recorded on admission and the end of the treatment. Results: No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P = 0.02 P = 0.01). Also, serum lactate and ALP levels decreased significantly in the KD group compared to the control group at the end of the intervention (10.7 ± 3 vs 13.3 ± 4, 149 ± 71 vs 240 ± 164, P = 0.02 and P = 0.007, respectively). A significant inverse association was observed between total carbohydrate intake and serum beta-hydroxybutyrate at 12 weeks (r = - 0.77 P < 0.001). No significant differences between groups were observed in thyroid hormones, electrolytes, albumin, LDH or ammonia. Compliance among KD subjects ranged from 66.7 to 79.2% as assessed by dietary intake and serum ketones levels of > 0.5. Conclusion: According to our results, besides a higher global quality of life and physical activity scores compared to the control group at 6 weeks, KD diet combined to chemotherapy in patients with breast cancer does not bring additional benefit about quality of life and physical activity at 12 weeks. However, decreases seen in levels of lactate and ALP in the KD group suggest that a KD may benefit patients with breast cancer. Trial registration: This trial has been registered on Iranian Registry of Clinical Trials (IRCT) under the identification code: IRCT20171105037259N2 https://www.irct.ir/trial/30755.
... Other studies have suggested enhanced cognitive function [9,13]. ...
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Introduction: Despite recent interest in the use of ketogenic diets (KDs) for cancer, evidence of beneficial effects is lacking. This study examined the impact of a randomly assigned KD on quality of life, physical activity and biomarkers in patients with breast cancer. Method: A total of 80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes were randomly assigned to either a KD or a control group for this 12-week trial. Concurrent with the first, third, and fifth chemotherapy sessions, quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones) were assessed. Dietary intake was also recorded on admission and the end of the treatment. Results: No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P=0.02 P= 0.01). Also, serum lactate and ALP levels decreased significantly in the KD group compared to the control group at the end of the intervention (10.7±3 vs 13.3±4, 149±71 vs 240±164, P=0.02 and P=0.007, respectively). A significant inverse association was observed between total carbohydrate intake and serum beta-hydroxybutyrate at 12 weeks (r= -0.77 P <0.001). No significant differences between groups were observed in thyroid hormones, electrolytes, albumin, LDH or ammonia. Compliance among KD subjects ranged from 66.7% to 79.2% as assessed by dietary intake and serum ketones levels of >0.5. Conclusion: According to our results, besides a higher global quality of life and physical activity scores compared to the control group at 6 weeks, KD diet combined to chemotherapy in patients with breast cancer does not bring additional benefit about quality of life and physical activity at 12 weeks. However, decreases seen in levels of lactate and ALP in the KD group suggest that a KD may benefit patients with breast cancer.
... A small trial in advanced cancer patients showed improvement in sleep and emotional function after a three-month KD intervention [12]. Other studies have suggested enhanced cognitive function [9,13]. ...
Preprint
Full-text available
Introduction: Despite recent interest in the use of ketogenic diets (KDs) for cancer , evidence of beneficial effects is lacking. This study examined the impact of a randomly assigned KD on quality of life, physical activity and biomarkers in patients with breast cancer. Method: A total of 80 patients with locally advanced or metastatic breast cancer and without a history of renal disease or diabetes were randomly assigned to either a KD or a control group for this 12-week trial. Concurrent with the first, third, and fifth chemotherapy sessions, quality of life, physical activity, and biomarkers (thyroid function tests, electrolytes, albumin, ammonia, ALP, lactate and serum ketones) were assessed. Dietary intake was also recorded on admission and the end of the treatment. Results: No significant differences were seen in quality of life or physical activity scores between the two groups after 12 weeks; however, the KD group showed higher global quality of life and physical activity scores compared to the control group at 6 weeks (P=0.02 P= 0.01). Also, serum lactate and ALP levels decreased significantly in the KD group compared to the control group at the end of the intervention (10.7±3 vs 13.3±4, 149±71 vs 240±164, P=0.02 and P=0.007, respectively). A significant inverse association was observed between total carbohydrate intake and serum beta-hydroxybutyrate at 12 weeks (r= -0.77 P <0.001). No significant differences between groups were observed in thyroid hormones, electrolytes, albumin, LDH or ammonia. Compliance among KD subjects ranged from 66.7% to 79.2% as assessed by dietary intake and serum ketones levels of >0.5. Conclusion: According to our results, chemotherapy combined with 6 weeks of a KD improved global quality of life and physical activity scores but did not result in similar improvements at 12 weeks. There were no significant differences noted in thyroid function or electrolyte levels between the two groups. However, decreases seen in levels of lactate and ALP in the KD group suggest that a KD may benefit patients with breast cancer
Chapter
Integrative and Functional Medicine Nutrition Therapy provides an evidence-based approach to oncology designed to enhance health-related quality of life and improve clinical outcomes through diet and nutrition, lifestyle interventions, detoxification, mind-body medicine, and alternative therapies. With conventional cancer treatment focused solely on the cancer, a strategy is needed to optimize outcomes that focus on the whole person. Toxicity, nutrient insufficiency and deficiency, poor diet, environmental exposures, emotional health, genetics-epigenetic potential, and low-grade inflammation are all factors affecting metabolism that contribute to both a cancer diagnosis and the outcome.
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Introduction: Crohn’s disease is regarded as having no curative treatment. Previous reports on dietary therapy of Crohn’s disease indicate no major success. Case Report: Here we report a severe case of Crohn’s disease where we successfully applied the paleolithic ketogenic diet. Dietary therapy resulted in resolution of symptoms, normalized laboratory parameters as well as gradual normalization of bowel inflammation as evidenced by imaging data and normalization of intestinal permeability as shown by the polyethylene glycol (PEG 400) challenge test. The patient was able to discontinue medication within two weeks. Currently, he is on the diet for 15 months and is free of symptoms as well as side effects. Conclusion: We conclude that the paleolithic ketogenic diet was feasible, effective and safe in the present case.
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Background Based on promising preclinical data, ketogenic diets (KDs) have been proposed as supplementary measures for cancer patients undergoing standard-of-care therapy. However, data is still scarce on the tolerability and effects of KDs on cancer patients undergoing radiotherapy (RT). Here we present six cases of patients who underwent RT and concurrently consumed a self-administered KD in our clinic within a busy community hospital setting. Methods All patients were followed prospectively with measurements of blood parameters, quality of life and body weight and composition using bioelectrical impedance analysis. Results No adverse diet-related side effects occurred. Two patients had no elevated ketone body levels in serum despite self-reporting compliance to the diet. There was consensus that the KD was satiating and weight loss occurred in all patients, although this was only significant in two patients. Our data indicate that weight loss was mainly due to fat mass loss with concurrent preservation of muscle mass. Overall quality of life remained fairly stable, and all subjects reported feeling good on the diet. Tumor regression occurred as expected in five patients with early stage disease; however one subject with metastatic small cell lung cancer experienced slight progression during three cycles of combined chemotherapy + KD and progressed rapidly after ending the KD. Conclusions Our data lend support to the hypothesis that KDs administered as supportive measures during standard therapy are safe and might be helpful in preservation of muscle mass. Further studies with control groups are needed to confirm these findings and address questions regarding any putative anti-tumor effects. Based on the experience with these six cases we implemented further steps to improve issues with KD compliance and initiated a clinical study that is described in a companion paper.
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Introduction: Currently, type 1 diabetes mellitus (T1DM) is treated with insulin and a high carbohydrate diet. In literature, there are studies indicating that low carbohydrate diets may be beneficial in reducing hypoglycemic episodes as well as the need for insulin. Previously, we reported a case of a 19-year-old T1DM patient who was successfully treated with a modified version of the ketogenic diet we refer to as the Paleolithic ketogenic diet. Case Report: A nine-year-old child with T1DM who initially was on an insulin regime with high carbohydrate diet then was put on the Paleolithic ketogenic diet. Following dietary shift glucose levels normalized and he was able to discontinue insulin. No hypoglycemic episodes occurred on the diet and several other benefits were achieved including improved physical fitness, reduction of upper respiratory tract infections and eczema. Currently, he is on the diet for 19 months. Conclusion: Adopting the Paleolithic ketogenic diet ensured normoglycemia without the use of external insulin. The diet was sustainable on the long-term. Neither complications nor side effects emerged on the diet. Keywords: C peptide, Ketogenic diet, Ketosis, Low carbohydrate diet, Paleolithic diet, Paleolithic ketogenic diet, Type 1 diabetes mellitus
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Paleolithic nutrition, which has attracted substantial public attention lately because of its putative health benefits, differs radically from dietary patterns currently recommended in guidelines, particularly in terms of its recommendation to exclude grains, dairy, and nutritional products of industry. We evaluated whether a Paleolithic nutritional pattern improves risk factors for chronic disease more than do other dietary interventions. We conducted a systematic review of randomized controlled trials (RCTs) that compared the Paleolithic nutritional pattern with any other dietary pattern in participants with one or more of the 5 components of metabolic syndrome. Two reviewers independently extracted study data and assessed risk of bias. Outcome data were extracted from the first measurement time point (≤6 mo). A random-effects model was used to estimate the average intervention effect. The quality of the evidence was rated with the use of the Grading of Recommendations Assessment, Development and Evaluation approach. Four RCTs that involved 159 participants were included. The 4 control diets were based on distinct national nutrition guidelines but were broadly similar. Paleolithic nutrition resulted in greater short-term improvements than did the control diets (random-effects model) for waist circumference (mean difference: -2.38 cm; 95% CI: -4.73, -0.04 cm), triglycerides (-0.40 mmol/L; 95% CI: -0.76, -0.04 mmol/L), systolic blood pressure (-3.64 mm Hg; 95% CI: -7.36, 0.08 mm Hg), diastolic blood pressure (-2.48 mm Hg; 95% CI: -4.98, 0.02 mm Hg), HDL cholesterol (0.12 mmol/L; 95% CI: -0.03, 0.28 mmol/L), and fasting blood sugar (-0.16 mmol/L; 95% CI: -0.44, 0.11 mmol/L). The quality of the evidence for each of the 5 metabolic components was moderate. The home-delivery (n = 1) and dietary recommendation (n = 3) RCTs showed similar effects with the exception of greater improvements in triglycerides relative to the control with the home delivery. None of the RCTs evaluated an improvement in quality of life. The Paleolithic diet resulted in greater short-term improvements on metabolic syndrome components than did guideline-based control diets. The available data warrant additional evaluations of the health benefits of Paleolithic nutrition. This trial was registered at PROSPERO (www.crd.york.ac.uk/PROSPERO) as CRD42014015119. © 2015 American Society for Nutrition.
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Purpose: Although the classical ketogenic diet is an effective treatment in childhood epilepsy, it is difficult to maintain on the long term due to side-effects and dislike. Methods: Here we report a case of a child with frequent epileptiform discharges confined to non-rapid-eye-movement (NREM) sleep and extensive cortical malformation. The child was started on a modified version of the classical ketogenic diet we refer to as the paleolithic ketogenic diet. Results: Subsequent follow-up electroencephalograms showed complete normalization of brain electric activity along with cognitive improvement. Neither antiepileptic medication nor vitamin supplements were used. The child strongly adhered to the diet as assessed by regular urinary ketone tests and laboratory work ups. Currently she is on the diet for 17 months. Neither side effects nor clinical signs of nutrient deficiency were observed. Conclusion: We conclude that the paleolithic ketogenic diet was effective, safe and feasible in this case.
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Gilbert’s syndrome (GS) is a common hyperbilirubinaemia syndrome caused by reduced conjugation of serum bilirubin by the liver. Although it is considered as a common and harmless condition not requiring treatment symptoms associated with GS may be unfavorable. Here we present a case of GS where high level of total and direct bilirubin, yellowish discoloration of the sclera as well as associated symptoms including migraine, fatigue and granulomatosus dermatitis were reversed following a shift toward the popular paleolithic and then toward the paleolithic ketogenic diet.
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Introduction: Metabolic syndrome is a major public health problem affecting at least 20% of the world’s adult population. Components of the metabolic syndrome include obesity, impaired glucose metabolism, hypertension and altered lipid profile. Currently, medical treatment relies on drugs. A major problem is that patients with long-standing disease are excessively medicated because of an increase in the number of symptoms over time. A few clinical studies indicate that low-carbohydrate diets, including the paleolithic as well as the ketogenic diet, may be beneficial in the treatment of conditions associated with the metabolic syndrome. Case Report: Herein, we present a case of patient with metabolic syndrome successfully treated with the paleolithic ketogenic diet. While on the diet the patient was able to discontinue eight medicines, lost weight, showed a continuous improvement in glucose parameters and her blood pressure normalized. Currently, the patient is on the paleolithic ketogenic diet for 22 months, free of symptoms and side effects. Conclusion: We conclude that the paleolithic ketogenic diet was safe, feasible and effective in the treatment of this patient with metabolic syndrome.
Chapter
Effects of a Ketogenic Diet on Tumor Metabolism and Nutritional Status in Pediatric Oncology Patients: Comments from Dr. Linda NebelingRaffi's Story: Comments from Miriam KalamianBiological Plausibility that Cancer is a Metabolic Disease Dependent for Growth on Glucose and Glutamine: Comments from Dr. Bomar HerrinUsing the Restricted Ketogenic Diet for Brain Cancer Management: Comments from Neuro-Oncologist, Dr. Kraig MooreThe Ketogenic Diet for Brain Cancer Management: Comments from Beth Zupec-KaniaSummaryReferences