Sancai Fengsui Decoction for RTOM: a Multicenter RCT

How to promote the prognosis and outcome of RTOM, restore oral function, and improvequality of life are key issues for improving the long‐term outcomes of head and neckmalignant tumor radiotherapy, and are also integral parts of the patient‐centeredTraditional Chinese Medicine "prevention‐treatment‐rehabilitation" system for RTOM. Thisproject aims to thoroughly evaluate the efficacy and safety of Chinese herbal compoundsin the rehabilitation phase of RTOM, targeting the long‐term rehabilitation outcomes ofRTOM, and to conduct a phase II clinical trial. In this project, Sancai Fengsui Decoctionwill be used as an oral medication to improve the rehabilitation status of RTOM, and willbe compared with a placebo group. The efficacy of the oral medication will be evaluatedby comparing outcome measures including the 2‐week pain relief rate in the oralcavity/oropharynx, the RTOG grade remission rate for RTOM, and the relief rate ofxerostomia. As an important extension of TCM prevention and treatment for RTOM, thisproject can provide a high‐level evidence‐based TCM protocol for the long‐termrehabilitation of RTOM.