Method: Study design was a double-blind RCT over 12 weeks with longitudinal data collection for a population of adults with oral squamous cell carcinoma receiving 7 weeks of conventional radiotherapy with/without chemotherapy. Study mouthrinses were prepared with/without a supercritical CO2 extract of the herb. Mouthrinse taste and tolerability, oral mucositis by Mouth and Throat Soreness (MTS) and Oral Mucositis Daily Questionnaire (OMDQ), patient self-efficacy by Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer), and oral Candida spp. were assessed at weekly study visits. Mouthrinse compliance was assessed via daily diary and mouthrinse bottle returns.
Result: Over the study period, 7 of 11 patients completed the protocol, 2 stopped radiotherapy, one died due to non-study reasons, and one withdrew secondary to chemotherapy side effects. Mouthrinses were generally reported as acceptable for taste and consistency. Recruitment was initially hampered by the inability to effectively track potentially eligible patients prior to starting radiotherapy. A sub-study of recruitment protocols identified the need for a real-time database of patients and for better patient education regarding clinical trial participation. The interval between patient identification and decision to begin radiotherapy ranged from days to months. Candida spp. were detected in the majority of patients. Further outcome details will be presented.
Conclusion: This feasibility study provided valuable experience and information essential for design and conduct of our planned phase II double-blind randomized controlled trial to determine the effect and mechanism of the study herbal mouthrinse to reduce the severity of oral mucositis in cancer patients undergoing conventional radiotherapy to the head and neck.