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.

BACKGROUND

Acute radiation-induced esophagitis (ARIE) is a common complication in non-small cell lung cancer (NSCLC) patients undergoing concurrent chemoradiotherapy (CCRT), negatively impacting their quality of life and treatment outcomes. Jishi Shuanghua Granules (JSG), a Traditional Chinese Medicine formulation, is widely used in clinical practice and has received positive feedback. However, high-quality evidence is still lacking. This study aims to evaluate the efficacy of JSG in reducing ARIE risk and severity and to explore its mechanisms through a multicenter, randomized, double-blind, placebo-controlled trial.

METHODS

A total of 240 stage III NSCLC patients scheduled to undergo definitive CCRT will be recruited and randomly assigned in a 1:1 ratio to either the JSG or placebo group. The primary efficacy endpoints will be the incidence rates of ARIE (≥Grade 1) and severe ARIE (SARIE, ≥Grade 3) based on the Radiation Therapy Oncology Group (RTOG) criteria. Secondary efficacy endpoints will include time to first occurrence of ARIE and SARIE, ARIE-related pain and dysphagia (assessed using the Numerical Rating Scale), quality of life (measured by the Functional Assessment of Cancer Therapy-Lung questionnaire), short-term lung cancer efficacy (objective response rate and disease control rate), and long-term outcomes (progression-free survival and overall survival). Additionally, the study will explore the mechanisms of JSG through multi-omics analyses, including lymphocyte subsets, inflammatory cytokines, oxidative stress markers, gut microbiota, and metabolomics.

DISCUSSION: If the trial meets its expected outcomes, this study will provide high-quality evidence supporting the use of JSG in preventing and treating ARIE. Furthermore, integrating multi-omics analyses will help elucidate the multi-target mechanisms of JSG, contributing to a more comprehensive evidence base.

CLINICAL TRIAL REGISTRATION: http://itmctr.ccebtcm.org.cn/, identifier [ITMCTR2025000641].