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
| Autor: | Mechthild Krause, Nadja Ebert, Christian Hannig, Anna Kensche, Steffen Löck, Wahyu Wijaya Hadiwikarta, Michael H. Baumann, Anna Hänsch, Wolfgang Dörr |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Time Factors medicine.medical_treatment Mouthwashes Kaplan-Meier Estimate Severity of Illness Index 030218 nuclear medicine & medical imaging 03 medical and health sciences Herbal tea 0302 clinical medicine Internal medicine medicine Clinical endpoint Mucositis Humans Radiology Nuclear Medicine and imaging Prospective Studies External beam radiotherapy Radiation Injuries Aged Proportional Hazards Models Aged 80 and over Stomatitis Chemotherapy DMF Index business.industry Head and neck cancer Polyphenols Chemoradiotherapy Cistaceae Middle Aged medicine.disease Radiation therapy Oncology Tolerability Head and Neck Neoplasms 030220 oncology & carcinogenesis Female business Teas Herbal Phytotherapy |
| Zdroj: | Strahlentherapie und Onkologie. 197:63-73 |
| ISSN: | 1439-099X 0179-7158 |
| Popis: | 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. 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. 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. 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. |
| Databáze: | OpenAIRE |
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