Chinese Herbal Oral Solution and Mouthwash to Shorten Severe Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients

What this Trial Is About

Researchers are studying the effects of a traditional Chinese medicine oral solution combined with a mouthwash on severe oral mucositis caused by radiotherapy in patients with head and neck cancers. The trial aims to find out if this treatment can shorten the duration of severe mucositis and whether it causes any side effects during radiotherapy. This Phase 2 study focuses on patients undergoing radiotherapy or concurrent chemoradiotherapy for non-metastatic head and neck tumors. Participants will start treatment when they develop severe oral mucositis (grade 3 or higher) during radiotherapy. They will receive Zishui Daohuo oral solution three times daily and Kuju mouthwash six times daily, or matching placebos. Treatment continues until two weeks after radiotherapy ends. After each dose, patients avoid eating, drinking, or oral hygiene for one hour to enhance mucosal contact. The study compares this combined traditional Chinese medicine approach to placebo treatment. During the study, patients will be monitored for the duration and onset time of severe and any-grade oral mucositis, relief rates, and adverse events. These assessments occur from radiotherapy start to up to eight weeks post-radiotherapy, with an evaluation period around 14 to 14.5 weeks. Safety is closely observed throughout radiotherapy. The total trial duration includes treatment and follow-up phases to evaluate both effectiveness and safety of the therapy.

Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.