Efficacy of Jishi Shuanghua Granules in preventing radiation-induced esophagitis in non-small cell lung cancer patients undergoing concurrent chemoradiotherapy: protocol for a multicenter, randomized, double-blind, placebo-controlled trial

The study examines the efficacy of Jishi Shuanghua Granules (JSG), a traditional Chinese medicine, in preventing radiation-induced esophagitis, a common complication in non-small cell lung cancer patients undergoing concurrent chemoradiotherapy. A multicenter randomized trial will enroll 240 stage III patients divided in a 1:1 ratio into JSG and placebo groups. The primary objective is to measure the incidence of esophagitis of any grade and severe esophagitis according to Radiation Therapy Oncology Group criteria. Secondary objectives include time to first occurrence of esophagitis, pain and swallowing difficulties, quality of life, treatment response, and long-term outcomes. The study will also investigate the mechanisms of JSG action through analyses including lymphocytes, inflammatory cytokines, oxidative stress markers, and gut microbiota.