Electro-acupuncture combined with adjuvant chemotherapy in gastric cancer (EAGER-2): a protocol for a multicenter randomized controlled trial

Background After undergoing gastrectomy, patients with gastric cancer frequently experience recurrence and metastasis. In our earlier research (EAGER trial, NCT04360577), we found that electro-acupuncture showed potential in extending disease-free survival (DFS) for gastric cancer patients receiving adjuvant chemotherapy. Nevertheless, the DFS data, a secondary outcome, was not yet mature, highlighting the need for robust, evidence-based studies to validate the advantages of electro-acupuncture in relation to DFS. Methods A multicenter, participant-blinded, sham-controlled, randomized trial involving 346 patients will be conducted in China. Participants will be allocated randomly in a 1:1 ratio to receive either electro-acupuncture or a sham acupuncture treatment (administered weekly, three times per chemotherapy cycle for four cycles) during their adjuvant chemotherapy. The selected acupoints will include GV20, EX-HN3, CV12, and bilateral PC6, ST36, SP6, SP4, and BL20. The primary outcome will be disease-free survival (DFS), while secondary measures will encompass health-related quality of life (HRQOL), symptom burden, Traditional Chinese Medicine symptom burden, overall survival, and chemotherapy completion rate. Discussion This study Trial registration The study was approved by the Ethics Committee of Guangdong Province Hospital of Chinese Medicine (approval number BF2024−351) with registration at ClinicalTrials.gov (TRN NCT07098949, Registration date 25 July 2025).