Article

Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (SPICE) trial: Protocol for a multicentre double-blind placebo-controlled randomised trial: Ginger and chemotherapy-induced nausea and emesis

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  • Nutrition Research Australia
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Abstract

Aim There is significant recent interest in the role of ginger root (Zingiber officinale) as an adjuvant therapy for chemotherapy‐induced nausea. The supplemental prophylactic intervention for chemotherapy‐induced nausea and emesis (SPICE) trial aims to assess the efficacy by reduced incidence and severity of chemotherapy‐induced nausea and vomiting, and enhanced quality of life, safety and cost effectiveness of a standardised adjuvant ginger root supplement in adults undergoing single‐day moderate‐to‐highly emetogenic chemotherapy. Methods Multisite, double‐blind, placebo‐controlled randomised trial with two parallel arms and 1:1 allocation. The target sample size is n = 300. The intervention comprises four capsules of ginger root (totalling 60 mg of active gingerols/day), commencing the day of chemotherapy and continuing for five days during chemotherapy cycles 1 to 3. The primary outcome is chemotherapy‐induced nausea‐related quality of life. Secondary outcomes include nutrition status; anticipatory, acute and delayed nausea and vomiting; fatigue; depression and anxiety; global quality of life; health service use and costs; adverse events; and adherence. Results During the five‐month recruitment period from October 2017 to April 2018 at site A only, a total of n = 33 participants (n = 18 female) have been enrolled in the SPICE trial. Recruitment is expected to commence at Site B in May 2018. Conclusions The trial is designed to meet research gaps and could provide evidence to recommend specific dosing regimens as an adjuvant for chemotherapy‐induced nausea and vomiting prevention and management.

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... This is a sub-study of the Supplemental Prophylactic Intervention for Chemotherapy Induced Nausea and Emesis (SPICE) trial [21]. The SPICE trial was a double-blind placebo-controlled trial that assessed the efficacy, safety, and cost-effectiveness of an adjuvant standardized ginger supplement in reducing chemotherapy-induced nausea and vomiting (Australian New Zealand Clinical Trials Registry ID 12616000416493) [21]. ...
... This is a sub-study of the Supplemental Prophylactic Intervention for Chemotherapy Induced Nausea and Emesis (SPICE) trial [21]. The SPICE trial was a double-blind placebo-controlled trial that assessed the efficacy, safety, and cost-effectiveness of an adjuvant standardized ginger supplement in reducing chemotherapy-induced nausea and vomiting (Australian New Zealand Clinical Trials Registry ID 12616000416493) [21]. The qualitative design and reporting of this study were developed according to the Qualitative Research Review Guidelines Guide to Peer-Reviewing Qualitative Manuscripts [22]. ...
... Characteristics of participants who participated in qualitative study interviews (N = 10; n = 4 control group of SPICE Trial; n = 6 intervention (ginger) group). [21] in which they were enrolled. ...
Article
Background and purpose: Minimal evidence regarding the safety and efficacy of complementary and alternative medicine (CAM) use during chemotherapy is accompanied with a high prevalence of use and nondisclosure to health professionals. This study aimed to explore patients’ perspectives, experiences, support needs, and sources of information regarding CAM use during chemotherapy. Materials and methods Semi-structured interviews with ten adult participants who recently completed chemotherapy treatment at a large hospital in Australia were transcribed verbatim. Three investigators thematically analysed the interviews. Results These participants receiving chemotherapy value CAMs as a natural complement to chemotherapy to improve wellbeing, with their use most strongly influenced by past experiences rather than expert advice. Conclusion Health professionals would benefit from education on how to best inform patients of the potential risks, harms and lack of efficacy for CAM use during chemotherapy in a way that does not lead to patient non-disclosure of CAM use.
... El estudio finalizó en abril-mayo de 2019. Si bien los resultados reportados en 2018 con base en 33 pacientes no son concluyentes, las expectativas de los investigadores están centradas en el prometedor efecto del suplemento de jengibre para mejorar CINV, así como la percepción de fatiga y el compromiso nutricional (51). ...
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Resumen Las náuseas y el vómito inducidos por la quimioterapia (CINV), constituyen un efecto colateral am-pliamente estudiado por su alto impacto sobre la calidad de vida de los pacientes que reciben este tratamiento oncológico. Actualmente están disponibles protocolos para el manejo farmacológico de CINV y adicionalmente, muchos pacientes utilizan de forma empírica alternativas fitoterapéuticas para manejar estos síntomas, entre ellas, el jengibre. Objetivo: La presente revisión tuvo como objetivo responder a la pregunta: ¿Es el jengibre un tratamiento eficaz contra las náuseas y el vómito inducidos por quimioterapia para el cáncer? Método: Se revisaron 14 ensayos aleatorizados con doble ciego y placebo controlado, publicados entre 2012 y 2018, en las bases de datos EMBASE y PubMed. Con-clusión: La evidencia clínica disponible es insuficiente para determinar la eficacia del jengibre en la reducción de CINV. Así pues, el uso de jengibre mejora las náuseas y los vómitos en varios pacientes, probablemente debido al efecto placebo.
... 13 Current therapies for the treatment and management of inflammation-related gastrointestinal conditions include a variety of medical, diet, and lifestyle recommendations [14][15][16][17] ; however, biophenols have recently gained interest as a possible adjuvant therapy for a range of conditions. [18][19][20] Biophenols, sometimes referred to as polyphenols, are phytochemicals found in foods such as extra virgin olive oil, peanuts, turmeric, ginger, tea, and peppermint. Although polyphenols are the more common term for such phytochmicals, they represent only phenolic compounds with two or more aromatic benzene rings. ...
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... The results of this systematic review and meta-analysis provide a rationale for further research such as that which is currently underway. 51 In line with recommendations from the previous systematic review, 13 additional randomized controlled trials with adequate sample sizes, standardized ginger products, use of validated outcome measures, and full reporting of data would better inform the evidence regarding the type of ginger supplement that should be recommended and the most effective dosing schedule. Study designs should also measure adverse events potentially relatable to the ginger intervention to determine the safety of the intervention. ...
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Introduction Studies suggest that the bioactive compounds contained within the rhizome of ginger (Zingiber officinale) could exert a beneficial effect on the symptoms of several chronic conditions (e.g. diabetes, arthritis) and in the reduction of nausea. However, it is unknown if ginger supplements and food products contain sufficient quantities of the necessary active ingredients to achieve a therapeutic effect. This study analyzed twenty commercially available ginger products including ginger dietary supplements, ginger spices (ground dried ginger), and ginger-containing drinks and food products and determined the concentration of [6]-, [8]- and [10]- gingerol and [6]- and [10]-shogaol. Methods The samples were extracted prior to separation by Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) and detected by ultraviolet (UV) spectrophotometry. Results Considerable variation between individual items within each food type was observed. Per gram, ginger supplements, particularly the standardized extracts, contained the greatest concentration of measured compounds (10.08 ± 7.92 mg, mean ± standard deviation), while the concentration of compounds within spices (9.29 ± 6.73 mg), beverages (1.77 ± 1.06 mg), confectionery (0.43 ± 0.32 mg), and teas (0.13 ± 0.00 mg) was considerably lower. When the concentration of compounds was measured per standardized serve, four ginger confectionery and beverage products contained total gingerol and shogaol concentrations that were similar to the analyzed dietary supplement. Conclusion Of the twenty commercially available ginger products examined, those with the highest content of active, antiemetic constituents were the standardized ginger extracts and supplements although ginger spices also showed high levels of active constituents per serve. In addition, standard deviation reveals a large variation within each product type.
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Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.
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The prevention of chemotherapy-induced vomiting has been improved by antiemetics, but nausea remains problematic. This study explores the concept that this is partly because patients use the term nausea to describe a cluster of symptoms. A total of 42 cancer patients currently being treated (n = 21) or at least 6 months of past treatment (median 3.5 years; n = 21) with experience of chemotherapy-induced nausea consented to semi-structured interviews about nausea, which were transcribed and analysed. There were 24 females and 18 males. The nature, number, location, duration and intensity of experiences described as nausea varied. Physical and psychological symptoms included dry retching, vomiting, anorexia, indigestion, change of taste, dizziness, bloating, reflux, inability to concentrate, fatigue and restlessness. Patients located nausea in sites ranging from the head/neck, sternum and mid and lower abdomen to the whole body. Some patients identified symptoms as part of the experience of nausea, and others described symptoms associated with nausea but separate from it. For most, distinguishing features of chemotherapy-induced (as opposed to other) nausea were its constant presence over time, fatigue and emotional associations with the cancer diagnosis. Triggers varied and included food (smells), negative emotions including anxiety, movement, smells (e.g., hand cream, cleaning products), treatment-related events, tooth brushing and mentioning nausea. Prescribed antiemetics were consistently noted as reducing the intensity of, but for many, not completely alleviating, nausea. Distraction and relaxation were preferred management techniques. Control of nausea will require treating the particular cluster of symptoms which a patient is experiencing as nausea.
Article
Chemotherapy-induced nausea and vomiting (CINV) is a common side-effect of cytotoxic treatment. It continues to affect a significant proportion of patients despite the widespread use of antiemetic medication. In traditional medicine, ginger (Zingiber officinale) has been used to prevent and treat nausea in many cultures for thousands of years. However, its use has not been confirmed in the chemotherapy context. To determine the potential use of ginger as a prophylactic or treatment for CINV, a systematic literature review was conducted. Reviewed studies comprised randomized controlled trials or crossover trials that investigated the anti-CINV effect of ginger as the sole independent variable in chemotherapy patients. Seven studies met the inclusion criteria. All studies were assessed on methodological quality and their limitations were identified. Studies were mixed in their support of ginger as an anti-CINV treatment in patients receiving chemotherapy, with three demonstrating a positive effect, two in favor but with caveats, and two showing no effect on measures of CINV. Future studies are required to address the limitations identified before clinical use can be recommended.
Article
Background: Beneficial effects of ginger in the treatment of gastrointestinal (GI) problems and chemotherapy-induced nausea and vomiting are well accepted. In rodents, the action of ginger seems to be mediated by the inhibition of 5-HT3 receptors, which are established targets to combat emesis and irritable bowel syndrome. Methods: Heterologously expressed human 5-HT3 A or 5-HT3 AB receptors were characterized by means of Ca(2+) influx studies using HEK293 cells. Complementing Ca(2+) measurements in Fluo-4-AM-stained whole-mount preparations of the human submucous plexus were carried out. Furthermore, [3H]GR65630 binding assays were performed to reveal the mode of action of ginger and its pungent compounds. Key results: We show for the first time that ginger extracts and its pungent arylalkane constituents concentration-dependently inhibit activation of human 5-HT3 receptors. Ginger extracts inhibited both receptors with increasing content of pungent compounds, confirming that these are part of ginger's active principle. Inhibition potencies of the arylalkanes 6-gingerol and 6-shogaol on both receptors were in the low micromolar range. A lipophilic ginger extract and 6-gingerol had no influence on 5-HT potency, but reduced the 5-HT maximum effect, indicating non-competitive inhibition. The non-competitive action was confirmed by [(3) H]GR65630 binding, showing that the ginger extract did not displace the radioligand from 5-HT3 A and 5-HT3 AB receptors. The potential relevance of the inhibitory action of ginger on native 5-HT3 receptors in the gut was confirmed in whole-mount preparations of the human submucous plexus. While a general neurotoxic effect of 6-gingerol was ruled out, it inhibited the 2-methyl-5-HT-mediated activation of 5-HT3 receptors residing on enteric neurons. Conclusions & inferences: Our findings may encourage the use of ginger extracts to alleviate nausea in cancer patients receiving chemotherapy and to treat functional GI disorders.
Article
Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect of chemotherapy, but it may be prevented or mitigated with medications. Uncontrolled CINV can lead to reduced quality of life and can result in increased costs (due to health care utilization and missed work). We prospectively assessed the prevalence and burden of CINV in a US population. Final analysis was performed on 178 patients, beginning chemotherapy during 2007-2008 at oncology specialty settings. Patients kept a diary recording use of antiemetic medications just before the start of chemotherapy and use of antiemetic medications, health care resources, and episodes of nausea and vomiting during the 5 days following. In addition, they completed a Functional Living Index-Emesis (FLIE) questionnaire and a Work Productivity and Assessment Inventory-Nausea and Vomiting assessment, to determine the impact of CINV on daily functioning and on work productivity, respectively. Physicians independently recorded prescribed medications and health care utilization. Of the patients, 61.2% reported experiencing CINV (34.3% with acute CINV and 58.4% with delayed CINV). Based on the FLIE assessment, 37.2% of all patients reported reduced daily functioning, and of those with poorly managed CINV, about 90% reported a significant impact on daily functioning. Total costs due to CINV were on average $778.58 per patient from the day of administration through the 5 days following the first cycle of chemotherapy; patients with more severe CINV typically had higher costs. CINV remains a significant problem among US patients, suggesting a need for more effective prophylaxis use in clinical practice.
Article
This study aimed to identify 1) the prevalence of malnutrition according to the scored Patient Generated-Subjective Global Assessment (PG-SGA), 2) utilization of available nutrition resources, 3) patient nutrition information needs, and 4) external sources of nutrition information. An observational, cross-sectional study was undertaken at an Australian public hospital on 191 patients receiving oncology services. According to PG-SGA, 49% of patients were malnourished, and 46% required improved symptom management and/or nutrition intervention. Commonly reported nutrition-impact symptoms included peculiar tastes (31%), no appetite (24%), and nausea (24%). External sources of nutrition information were accessed by 37%, with popular choices being media/Internet (n = 19) and family/friends (n = 13). In a subsample (n = 65), 32 patients were aware of the available nutrition resources, 23 thought the information sufficient, and 19 patients had actually read them. Additional information on supplements and modifying side effects was requested by 26 patients. Malnutrition is common in oncology patients receiving treatment at an Australian public hospital, and almost half require improved symptom management and/or nutrition intervention. Patients who read the available nutrition information found it useful; however, awareness of these nutrition resources and the provision of information on supplementation and managing symptoms requires attention.
Article
To review the literature of the validity of the Hospital Anxiety and Depression Scale (HADS). A review of the 747 identified papers that used HADS was performed to address the following questions: (I) How are the factor structure, discriminant validity and the internal consistency of HADS? (II) How does HADS perform as a case finder for anxiety disorders and depression? (III) How does HADS agree with other self-rating instruments used to rate anxiety and depression? Most factor analyses demonstrated a two-factor solution in good accordance with the HADS subscales for Anxiety (HADS-A) and Depression (HADS-D), respectively. The correlations between the two subscales varied from.40 to.74 (mean.56). Cronbach's alpha for HADS-A varied from.68 to.93 (mean.83) and for HADS-D from.67 to.90 (mean.82). In most studies an optimal balance between sensitivity and specificity was achieved when caseness was defined by a score of 8 or above on both HADS-A and HADS-D. The sensitivity and specificity for both HADS-A and HADS-D of approximately 0.80 were very similar to the sensitivity and specificity achieved by the General Health Questionnaire (GHQ). Correlations between HADS and other commonly used questionnaires were in the range.49 to.83. HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.
Article
A prospective longitudinal study was designed to assess the role of pretreatment proneness to nausea and vomiting (NV) in the development of postchemotherapy NV in a group of Chinese breast cancer patients receiving moderately highly emetogenic chemotherapy. Seventy-one chemotherapy-naive subjects participated in the study. Patients were assessed the day before chemotherapy with measurements of their anxiety level, depression, fatigue and proneness to NV, motion sickness, NV experienced in past pregnancies, history of labyrinthitis, expectation of developing NV and expectation of developing pain. Patients also completed daily assessments of frequency, duration and intensity of NV for the 7 days after chemotherapy. Regression analyses revealed that nonpharmacological factors explained part of the variance of NV, the most common predictors being a history of labyrinthitis, expectation of developing NV after chemotherapy, younger age, stage of disease, and state anxiety. The explanatory power of the models ranged from 6% to 23% of the variance of the independent variable. There were different explanatory models for acute and delayed NV. Results indicate that consideration of the role of nonpharmacological factors in the development of NV could lead to more effective management of NV induced by chemotherapy.
Article
To evaluate the use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. An observational study assessing the nutritional status of patients with cancer. Oncology ward of a private tertiary Australian hospital. Seventy-one cancer patients aged 18-92 y. Scored PG-SGA questionnaire, comparison of scored PG-SGA with subjective global assessment (SGA), sensitivity, specificity. Some 24% (17) of 71 patients were well nourished, 59% (42) of patients were moderately or suspected of being malnourished and 17% (12) of patients were severely malnourished according to subjective global assessment (SGA). The PG-SGA score had a sensitivity of 98% and a specificity of 82% at predicting SGA classification. There was a significant difference in the median PG-SGA scores for each of the SGA classifications (P<0.001), with the severely malnourished patients having the highest scores. Re-admission within 30 days of discharge was significantly different between SGA groups (P=0.037). The mortality rate within 30 days of discharge was not significantly different between SGA groups (P=0.305). The median length of stay of well nourished patients (SGA A) was significantly lower than that of the malnourished (SGA B+C) patients (P=0.024). The scored PG-SGA is an easy to use nutrition assessment tool that allows quick identification and prioritisation of malnutrition in hospitalised patients with cancer.
Article
Malnutrition is frequent in cancer. The objective of this study was to determine the prevalence, in Spain, of malnutrition in cancer patients with advanced disease and to assess the therapeutic focus. A total of 781 patients were evaluated to determine individual nutritional status using the Scored Patient Generated-Subjective Global Assessment (Scored PG-SGA) questionnaire. Almost 60% of the patients included were receiving cancer treatment. Patients with the highest weight loss were those with tumours of oesophagus (57%), stomach (50%) and larynx (47%). Serious eating problems were encountered by 68% of the patients; the principal problem being anorexia (42.2%). The median number of symptoms impeding food intake was 2. According to the Scored PG-SGA, 52% of the patients were moderately or severely malnourished and 97.6% required some form of nutritional intervention/recommendation. (a) the majority of patients in the study needed nutritional intervention; (b) more than 50% had moderate or severe malnutrition; (c) the Scored PG-SGA is a useful and simple tool for evaluating nutritional status and contains additional information on nutritional recommendations; (d) nutritional evaluation of the cancer patients needs to be improved so as to offer better treatment of symptoms and to improve the patient's quality of life.
Article
Chemotherapy-induced nausea and vomiting (CINV) are major adverse effects of cancer chemotherapy. We compared the impact of acute (during the first 24 hours postchemotherapy) and delayed (days 2 through 5 postchemotherapy) CINV on patients' quality of life (QoL) after highly or moderately emetogenic chemotherapy (HEC and MEC, respectively). This prospective, multicenter, multinational study was conducted in 14 medical practices on cancer patients undergoing either HEC or MEC treatment. Patients recorded episodes of nausea and vomiting in a diary. Patients completed the Functional Living Index-Emesis (FLIE) questionnaire at baseline and on day 6. A total of 298 patients were assessable (67 HEC patients, 231 MEC patients). Emesis was reported by 36.4% of patients (13.2% acute, 32.5% delayed) and nausea by 59.7% (36.2% acute, 54.3% delayed). HEC patients reported significantly lower mean FLIE total score than MEC patients (95.5 v 107.8 respectively; P = .0049). Among all patients, the nausea score was significantly lower than the vomiting score (50.0 and 55.3, respectively; P = .0097). Of the 173 patients who experienced neither vomiting nor nausea during the first 24 hours postchemotherapy, 22.9% reported an impact of CINV on daily life caused by delayed CINV. CINV continues to adversely affect patients' QoL despite antiemetic therapy even after treatment with only moderately emetogenic chemotherapy regimens, and even in the subgroup of patients who do not experience nausea and vomiting during the first 24 hours. On the basis of the FLIE results in this study, nausea had a stronger negative impact on patients' daily lives than vomiting.
Article
There is a lack of clinical tools to facilitate communication between clinicians and patients about chemotherapy-induced nausea and vomiting (CINV). The Multinational Association of Supportive Care in Cancer (MASCC) has developed such a tool, which is an eight-item scale for the assessment of acute and delayed nausea and vomiting, and is completed once per cycle of chemotherapy. The aim of the current study was to assess its psychometric properties, specifically reliability and validity, cultural transferability and equivalence, and congruence with proxy assessments, as well as to determine if accuracy of recall of CINV events using the MASCC Antiemesis Tool (MAT) differed over time from chemotherapy. A prospective study was carried out with adult cancer patients and their informal carers from two hospitals, one each in the United Kingdom (UK) and United States of America (U.S.). Patients completed the Rhodes Index for nausea, vomiting and retching (INVR) daily for the first five days after chemotherapy and were then asked to complete the MAT at one week, two weeks, or three weeks after chemotherapy. Carers completed an adapted MAT concurrently with patients. The sample consisted of 87 patients and 22 informal carers. The internal consistency reliability of the scale was high, with Cronbach alphas of 0.77 (patient sample) and 0.82 (carer sample). Responses were similar between the UK and U.S. samples in terms of nausea and vomiting, and both samples found the scale easy to use. Contrasted-groups validity (using age as a grouping variable) and concurrent validity (MAT compared with INVR) suggested that the scale is sensitive to detect the different dimensions of CINV and performed well against a daily assessment of nausea/vomiting (total score correlation r=0.86, P<0.001). Recall of events was high even three weeks after chemotherapy (correlations with INVR of 0.44-0.99, all P<0.01). Factor analysis clearly identified three factors, namely vomiting, acute nausea, and delayed nausea. Proxy assessments by carers were congruent with the patients' responses, especially in relation to vomiting. The MAT is a reliable, valid, clear, and easy-to-use clinical tool that could facilitate discussion between clinicians and patients about their nausea and vomiting experience, thereby potentially aiding treatment decisions. Regular assessment of nausea and vomiting after chemotherapy has the potential to significantly improve CINV management.
Article
The assessment of chemotherapy-induced nausea, vomiting and retching (CINVR) is important and to date no review has comprehensively assessed available patient self-report tools. The aim was to undertake a review of their utility, content and psychometric properties. One thousand three hundred and forty-seven citations were identified by electronic and hand searches resulting in 24 non-duplicate abstracts, 15 articles for analysis, and six articles, which fitted the inclusion criteria. E-mail investigations discovered a further scale, resulting in seven measures. The review highlighted the strengths and weaknesses of current tools. The multiple domains, phases and aspects of CINVR signify that the assessment tools varied markedly. The diverse requirements of research and clinicians also contribute to the variation. There was a notable disparity in the quality of scales and paucity in terms of their development and psychometric evaluation. We found that several self-assessment scales currently perceived as well-validated tools have problems in terms of their validity, reliability and appropriateness. The constituents of a scale relevant for both clinical and research use were assessed and it was recommended that a modular tool focusing on two domains (nausea and vomiting); two phases (acute and delayed); measuring the aspects of occurrence, frequency, intensity alongside duration and functional interference; and antiemetic use and adverse events should be developed. Based on these recommendations, further research into an appropriate scale would minimise conceptual confusion, increase clinicians' understanding and control of CINVR, decrease patient distress and could have equal utility in both a clinical and a research setting.
Note for Guidance on Good Clinical Practice (CPMP/ ICH/135/95)
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TGA. Note for Guidance on Good Clinical Practice (CPMP/ ICH/135/95). Therapeutic Goods Administration, 2000.
Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95).Therapeutic Goods Administration
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