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.
Strahlenther Onkol
; 197(1): 63-73, 2021 Jan.
Article
en En
| MEDLINE
| ID: mdl-32970162
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 ttest and log rank test.RESULTS:
Data from 57 patients could be evaluated. Patient characteristics showed no significant difference between the two groups (nâ¯= 27 sage; nâ¯= 30 Cystus®). A total of 55 patients received the prescribed dose (60-66â¯Gy postoperative; 70-76.8â¯Gy primary). Mucositis grade 3 was observed in 23 patients (nâ¯= 11 sage; nâ¯= 12 Cystus®) and occurred between day 16 and 50 after start of therapy. There was no significant difference between the two groups in latency (pâ¯= 0.75) and frequency (pâ¯= 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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Traumatismos por Radiación
/
Estomatitis
/
Cistaceae
/
Polifenoles
/
Tés de Hierbas
/
Neoplasias de Cabeza y Cuello
/
Fitoterapia
/
Antisépticos Bucales
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Strahlenther Onkol
Asunto de la revista:
NEOPLASIAS
/
RADIOTERAPIA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Alemania