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Results of a randomized controlled phase III trial: efficacy of polyphenol-containing cystus® tea mouthwash solution for the reduction of mucositis in head and neck cancer patients undergoing external beam radiotherapy

DOI:10.1007/s00066-020-01684-y
Authors:
Nadja Ebert at German Cancer Research Center
Nadja Ebert
Anna Kensche
Anna Kensche
Anna Kensche
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Steffen Löck at OncoRay- Center for Radiation Research in Oncology
Steffen Löck
Wahyu Wijaya Hadiwikarta at German Cancer Research Center
Wahyu Wijaya Hadiwikarta
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Abstract and Figures

Purpose: To determine the effect of Cystus® tea (Naturprodukte Dr. Pandalis GmbH & Co. KG) as mouthwash compared to sage tea on oral mucositis in patients undergoing radio(chemo)therapy for head and neck cancer. Methods: In this randomized, prospective phase III study, 60 head and neck cancer patients with primary or postoperative radio(chemo)therapy were included between 04/2012 and 06/2014. They received either sage or Cystus® tea for daily mouthwash under therapy. Mucositis was scored twice a week following the Radiation Therapy Oncology Group and the European Organization for Research and Treatment Cancer (RTOG/EORTC) scoring system. Dental parameters were also recorded. Statistical evaluation of the primary endpoint was performed using t‑test and log rank test. Results: Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the two groups (n = 27 sage; n = 30 Cystus®). A total of 55 patients received the prescribed dose (60-66 Gy postoperative; 70-76.8 Gy primary). Mucositis grade 3 was observed in 23 patients (n = 11 sage; n = 12 Cystus®) and occurred between day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (p = 0.75) and frequency (p = 0.85) of the occurrence of mucositis grade 3. The self-assessment of the oral mucosa and the tolerability of the tea also showed no significant differences. Occurrence of dental pathologies appeared to increase over time after radiotherapy. Conclusion: Cystus® and sage tea have a similar effect on the occurrence of radiation-induced mucositis regarding latency and incidence. Cystus® tea mouthwash solution is tolerated well and can be applied in addition to intensive oral care and hygiene along with the application of fluorides.
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ORIGINAL ARTICLE
https://doi.org/10.1007/s00066-020-01684-y
Strahlenther Onkol (2021) 197:63–73
Results of a randomized controlled phase III trial: efficacy of
polyphenol-containing cystus®tea mouthwash solution for the
reduction of mucositis in head and neck cancer patients undergoing
external beam radiotherapy
Nadja Ebert1,2,3,4,5 · Anna Kensche6·SteenLöck
2,3,4,5 · Wahyu Wijaya Hadiwikarta1· Anna Hänsch6·
Wolfgang Dörr · Mechthild Krause1,2,3,4,5,7,8,9 · Christian Hannig6·MichaelBaumann
1,2,3,5,10
Received: 24 April 2020 / Accepted: 24 August 2020 / Published online: 24 September 2020
© Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract
Purpose To determine the effect of Cystus®tea (Naturprodukte Dr. Pandalis GmbH & Co. KG) as mouthwash compared
to sage tea on oral mucositis in patients undergoing radio(chemo)therapy for head and neck cancer.
Methods In this randomized, prospective phase III study, 60 head and neck cancer patients with primary or postoperative
radio(chemo)therapy were included between 04/2012 and 06/2014. They received either sage or Cystus®tea for daily
mouthwash under therapy. Mucositis was scored twice a week following the Radiation Therapy Oncology Group and the
European Organization for Research and Treatment Cancer (RTOG/EORTC) scoring system. Dental parameters were also
recorded. Statistical evaluation of the primary endpoint was performed using t-test and log rank test.
Results Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the
two groups (n= 27 sage; n=30 Cystus
®). A total of 55 patients received the prescribed dose (60–66Gy postoperative;
70–76.8 Gy primary). Mucositis grade 3 was observed in 23 patients (n= 11 sage; n=12 Cystus
®) and occurred between
day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (p= 0.75) and
frequency (p= 0.85) of the occurrence of mucositis grade 3. The self-assessment of the oral mucosa and the tolerability
of the tea also showed no significant differences. Occurrence of dental pathologies appeared to increase over time after
radiotherapy.
C. Hannig und M. Baumann share last co-authorship.
Availability of data and material Data were stored at the
Department of Radiation Oncology, except for the dental
parameters that were stored at the Clinic of Operative Dentistry at
the University Medical Center Carl Gustav Carus in Dresden. The
data are not deposited in a repository.
Code availability Statistical analysis and graph creations were
performed using R version 3.5.0 (2018-04-23).
Dr. med. Nadja Ebert
nadja.ebert@uniklinikum-dresden.de
1German Cancer Research Center (DKFZ), Heidelberg,
Germany
2Department of Radiotherapy and Radiation Oncology,
Faculty of Medicine and University Hospital Carl Gustav
Carus, Technische Universität, Dresden, Germany
3OncoRay—National Center for Radiation Research in
Oncology, Faculty of Medicine and University Hospital Carl
Gustav Carus, Technische Universität, Dresden, Germany
4German Cancer Consortium (DKTK), Partner Site Dresden,
and German Cancer Research Center (DKFZ), Heidelberg,
Germany
5Faculty of Medicine and University Hospital Carl Gustav
Carus, Technische Universität Dresden, Dresden, Germany
6Clinic of Operative and Pediatric Dentistry, Faculty of
Medicine and University Hospital Carl Gustav Carus,
Technische Universität, Dresden, Germany
7Helmholtz-Zentrum Dresden — Rossendorf, Institute of
Radiooncology — OncoRay, Dresden, Germany
8National Center for Tumor Diseases (NCT), Partner Site
Dresden, Dresden, Germany
9Helmholtz Association/Helmholtz-Zentrum
Dresden—Rossendorf (HZDR), Dresden—Rossendorf,
Germany
10 Ruprecht-Karls-University, Heidelberg, Germany
K
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... In this context, promising results from a clinical trial suggests the use of cistus incanus tea in patients with mucositis or treatment-related radiation-induced oral mucositis [261]. Thereby, cistus incanus had an effect on the occurrence of mucositis regarding latency and incidence [261]. ...
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Article
  • Apr 2019
This review assesses the development of oral health habits and status in European adults (35-44 years old) and senior citizens (65-74 years old) over the period of 1996-2016. There seem to be good opportunities for improving oral health habits by brushing twice daily with fluoride toothpaste among adults, as only 33-85% reported doing so. Caries experience was extensive among adults (≥92%). In adults of 23 countries, the mean DMFT score ranged from 6.6 to 17.6 (median 12.1). In senior citizens of 21 countries, the mean DMFT score varied from 14.7 to 25.5 (median 22.0). Repeated cross-sectional studies on caries trends in adults revealed a reduction of the DMFT value by 20%, referring to country-wide data. Among senior citizens, the corresponding reduction was 13%, with a shift in the DMFT components, i.e., with lower MT and higher FT scores. Edentulousness in the age group of 35- to 44-year-olds started disappearing in Europe from the year 2000, and had been markedly reduced in some countries during the last decade. However, the eradication of edentulousness among 65- to 74-year-olds has not yet been reported. Further epidemiological surveys should apply caries diagnostic criteria that, besides representing our contemporary understanding of oral health care, allow comparisons with previous surveys using the WHO criteria. In conclusion, in the last two decades, a decline in caries was observed among European adults, and to a lesser extent among senior citizens. It is expected that the decline in caries will contribute to better oral health of individuals.
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Identification of New Compounds from Sage Flowers ( Salvia officinalis L.) as Markers for Quality Control and the Influence of the Manufacturing Technology on the Chemical Composition and Antibacterial Activity of Sage Flower Extracts
Article
  • Feb 2018
Parts of Salvia species such as its flowers and leaves are currently used as a culinary herb and for some medicinal applications. To distinguish the different sage extracts it is necessary to analyze their individual chemical compositions. Their characteristic compounds might be established as markers to differentiate between sage flowers and leaf extracts or to determine the manufacturing technology and storage conditions. Tri-p-coumaroylspermidine can be detected only in flowers and has been described here for Salvia and Lavandula species for the first time. Markers for oxidation processes are the novel compounds salviquinone A and B, which were generated from carnosol by contact with oxygen. Caffeic acid ethyl ester was established as an indirect marker for the usage of ethanol as extraction solvent. The compounds were identified by LC-QTOF-HRESIMS, LC-MS, NMR, IR, and single-crystal X-ray diffraction after isolation by semipreparative HPLC. Furthermore, sage flower resin showed interesting antibacterial in vitro activities against Gram-positive and Gram-negative bacteria.
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Pre-Radiation dental considerations and management for head and neck cancer patients
Article
Treatment of head and neck cancer (HNC) is accompanied by a high rate of morbidity, and complications can have a lifelong, profound impact on both patients and caregivers. Radiation-related injury to the hard and soft tissue of the head and neck can significantly decrease patients’ quality of life. The purpose of this study is to provide patent-specific guidelines for managing the oral health and related side effects of HNC patients treated with radiation therapy. Based on reviewed articles retrieved on the PubMed database, guidelines for management of the oral health of this patient population were organized into three separate categories: cancer, patient, and dentition. The location, type, and staging of the cancer, along with the radiation used to treat the cancer significantly impact dental treatment. Several unique patient characteristics such as motivation, presence of support system, socioeconomic status, nutrition, and race have all been found to affect outcomes. Dental disease and available supportive dental management was found to significantly impact treatment and quality of life in this patient population. By comprehensively assessing unique cancer, patient, and dental-related factors, this review provides individualized evidence-based guidelines on the proper management of this complex and vulnerable patient population.
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Compliance of post-radiation therapy head and neck cancer patients with caries preventive protocols
Article
Background: Caries prevention is paramount in safeguarding the life quality of head and neck cancer patients and is dependent on patient compliance with caries preventive protocols. The purpose of this study was to examine this compliance. Methods: All records of patients referred to one public oral medicine clinic servicing a head and neck oncology unit of one major Western Australian hospital, between January 2005 and December 2011 were examined. Data extracted included patient and cancer characteristics and compliance with dietary advice, dental care, oral hygiene instruction and fluoride use over a follow-up period of at least 12 months. Compliance was assessed against various oral health outcomes and patient characteristics. Results: Of the 116 participants, 75.9% complied with all caries preventive measures over a mean follow-up period of 45 months. Non-compliance with regular dental attendance (p=0.004), oral hygiene instruction (p=0.009), dietary advice (p=0.034) and daily fluoride use (p=0.018) were associated with the development of dental caries post-treatment. The presence of dental caries at the time of cancer diagnosis was predictive of poorer compliance. Conclusion: High compliance with caries preventive measures is attainable in the head and neck cancer patient group. Factors other than fluoride use seem important in caries prevention. This article is protected by copyright. All rights reserved.
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The Polyphenolic Composition of Cistus incanus Herbal Tea and Its Antibacterial and Anti-adherent Activity against Streptococcus mutans
Article
The Mediterranean plant Cistus incanus is rich in polyphenols and has shown several pharmacological activities, mainly antibacterial effects. Furthermore, in situ studies revealed that a C. incanus infusion reduces the initial bacterial adhesion in the oral cavity due to the polyphenols, an indication that C. incanus might reduce the risk of caries disease. In the present study, the polyphenols from four different commercial C. incanus herbal teas were extracted by standardized accelerated solvent extraction for in vitro tests and by an infusion for in situ tests. Both extracts were characterized qualitatively and quantitatively by high-performance liquid chromatography and only the polyphenol content differed slightly. By means of diode array detection and mass spectrometry, 29 polyphenols, including ellagitannins, flavanols, and glycosylated flavonols, were identified. Thereby, only quantitative but no qualitative differences between the four samples were detected. Furthermore, the in vitro antibacterial activity of the C. incanus accelerated solvent extracts against Streptococcus mutans, one of the primary cariogenic bacterial species, was examined using a live/dead assay (BacLight®). With this approach, C. incanus yielded antibacterial properties. Additional in situ experiments indicated that rinses with a C. incanus infusion reduced the initial bacterial colonization of enamel samples exposed to oral fluids for over eight hours. Furthermore, it was shown by transmission electron microscopy that the application of a C. incanus infusion modifies the ultrastructure of the acquired enamel pellicle, yielding a more electron-dense morphology. It can be assumed that the polyphenols are responsible for the observed effects. Georg Thieme Verlag KG Stuttgart · New York.
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