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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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