Clinical Trial

Sancai Fengsui Decoction for RTOM: A Multicenter RCT

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
How to promote the prognosis and outcome of RTOM, restore oral function, and improve quality of life are key issues for improving the long-term outcomes of head and neck malignant tumor radiotherapy, and are also integral parts of the patient-centered Traditional Chinese Medicine "prevention-treatment-rehabilitation" system for RTOM. This project aims to thoroughly evaluate the efficacy and safety of Chinese herbal compounds in the rehabilitation phase of RTOM, targeting the long-term rehabilitation outcomes of RTOM, and to conduct a phase II clinical trial. In this project, Sancai Fengsui Decoction will be used as an oral medication to improve the rehabilitation status of RTOM, and will be compared with a placebo group. The efficacy of the oral medication will be evaluated by comparing outcome measures including the 2-week pain relief rate in the oral cavity/oropharynx, the RTOG grade remission rate for RTOM, and the relief rate of xerostomia. As an important extension of TCM prevention and treatment for RTOM, this project can provide a high-level evidence-based TCM protocol for the long-term rehabilitation of RTOM.
Trial Details
NCT Number NCT07692997
Lead Sponsor Nanfang Hospital, Southern Medical University
Conditions Radiation-Induced Oral Mucositis (RTOM), Head and Neck Cancer, Oral Mucositis of RTOG Grade Greater Than 1
Enrollment 126 participants
Start Date 2026-08-01
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-09