Nadja Ebert1,2,3,4,5, Anna Kensche6, Steffen Löck7,8,9,10, Wahyu Wijaya Hadiwikarta11, Anna Hänsch6, Wolfgang Dörr, Mechthild Krause11,7,8,9,10,12,13,14, Christian Hannig6, Michael Baumann11,7,8,10,15. 1. German Cancer Research Center (DKFZ), Heidelberg, Germany. nadja.ebert@uniklinikum-dresden.de. 2. Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany. nadja.ebert@uniklinikum-dresden.de. 3. OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany. nadja.ebert@uniklinikum-dresden.de. 4. German Cancer Consortium (DKTK), Partner Site Dresden, and German Cancer Research Center (DKFZ), Heidelberg, Germany. nadja.ebert@uniklinikum-dresden.de. 5. Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. nadja.ebert@uniklinikum-dresden.de. 6. Clinic of Operative and Pediatric Dentistry, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany. 7. Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany. 8. OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany. 9. German Cancer Consortium (DKTK), Partner Site Dresden, and German Cancer Research Center (DKFZ), Heidelberg, Germany. 10. Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. 11. German Cancer Research Center (DKFZ), Heidelberg, Germany. 12. Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology - OncoRay, Dresden, Germany. 13. National Center for Tumor Diseases (NCT), Partner Site Dresden, Dresden, Germany. 14. Helmholtz Association/Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden-Rossendorf, Germany. 15. Ruprecht-Karls-University, Heidelberg, Germany.
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 (60-66 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.
RCT Entities:
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 cancerpatients 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.
Authors: Joel B Epstein; Jennifer L Beaumont; Clement K Gwede; Barbara Murphy; Adam S Garden; Ruby Meredith; Quynh-Thu Le; David Brizel; John Isitt; David Cella Journal: Cancer Date: 2007-05-01 Impact factor: 6.860
Authors: Kenneth Kufta; Michael Forman; Samuel Swisher-McClure; Thomas P Sollecito; Neeraj Panchal Journal: Oral Oncol Date: 2017-12-06 Impact factor: 5.337
Authors: Catherine H L Hong; Joel J Napeñas; Brian D Hodgson; Monique A Stokman; Vickie Mathers-Stauffer; Linda S Elting; Fred K L Spijkervet; Michael T Brennan Journal: Support Care Cancer Date: 2010-05-07 Impact factor: 3.603
Authors: Rajesh V Lalla; Joanne Bowen; Andrei Barasch; Linda Elting; Joel Epstein; Dorothy M Keefe; Deborah B McGuire; Cesar Migliorati; Ourania Nicolatou-Galitis; Douglas E Peterson; Judith E Raber-Durlacher; Stephen T Sonis; Sharon Elad Journal: Cancer Date: 2014-02-25 Impact factor: 6.860