Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients
Status:
Not yet recruiting
Trial end date:
2024-11-30
Target enrollment:
Participant gender:
Summary
Approximately 60% and 90% of patients with head and neck (H&N) cancers receiving standard
radiotherapy (RT) and chemoradiotherapy (chemo-RT) will develop oral mucositis respectively.
Oral mucositis (OM) is one of the dose-limiting adverse events which can also lead to
emotional and nutritional problems. Clinically, it is usually observed by the end of first
week of RT (after 10 Gy) and reaches peak damage in 14-21 days or by the end of treatment.
Healing then takes approximately 2 to 3 weeks after completion of RT. For the Chinese
Medicine (CM) interventions, many studies have been reviewed on the efficacy of mouthwash or
internal herbal decoction to OM. Although some positive results were observed, most of them
were performed by applying different assessment tools and lack of quality of life (QOL) or
self-reported symptoms assessment. In addition, the intervention time and follow-up period
were usually insufficient (stopped at the end of RT), therefore they could not review the
long-term efficacy of CM according to normal progression of OM and the safety of using CM.
Therefore, we hope this pilot study can evaluate the efficacy and safety of CM in a strict
protocol.