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.

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.

• Authors: Nadja Ebert, Anna Kensche, Steffen Löck, Wahyu Wijaya Hadiwikarta, Anna Hänsch, Wolfgang Dörr, Mechthild Krause, Christian Hannig, Michael Baumann
• Journal: Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] (Strahlenther Onkol) Vol. 197 Issue 1 Pg. 63-73 (Jan 2021) ISSN: 1439-099X [Electronic] Germany
• PMID: 32970162 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Mouthwashes
• Polyphenols
• Teas, Herbal

Topics

• Aged
• Aged, 80 and over
• Chemoradiotherapy (adverse effects)
• Cistaceae (chemistry)
• DMF Index
• Female
• Head and Neck Neoplasms (radiotherapy)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Mouthwashes (therapeutic use)
• Phytotherapy
• Polyphenols (therapeutic use)
• Proportional Hazards Models
• Prospective Studies
• Radiation Injuries (drug therapy, etiology, prevention & control)
• Severity of Illness Index
• Stomatitis (drug therapy, etiology, prevention & control)
• Teas, Herbal
• Time Factors