Effect of Traditional Chinese Medicine Collaborative Model (TCMCM) combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer: Protocol for a Randomized Controlled Trial

Abstract BackgroundMetastasis and/or recurrence are the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIb and IIIc are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages. Herbal medicines are natural substances that have been used for centuries in China, auricular acupressure and acupoints has shown promise in reducing side effects of chemotherapy，this traditional Chinese medicine collaborative model（TCMCM）has been studied in cancer, however, the specific effects have not been systematically evaluated. This study was designed to evaluate whether TCMCM can decrease adverse effects after chemotherapy and reduce the recurrence rate and metastasis in stage IIIb and IIIc gastric cancer. Method/designThis prospective，multicenter, randomized, open-label trail will recruit 260 patients with stage IIIb and IIIc gastric cancer who undergo radical surgery with D2 lymphadenectomy. Randomization to usual adjuvant chemotherapy or the intervention (TCMCM) with a 1:1 ratio will be used. Patients in the intervention group received an oral traditional Chinese formula, auricular acupressure and acupoints, all participants will be continuing to receive usual adjuvant chemotherapy. The primary outcome is 3-year disease free survival rate. Secondary outcomes include quality of life，side effects caused by chemotherapy and safety outcome measures. Assessments will be performed at Screening period and 4，8 cycles after adjuvant chemotherapy，9, 12, 18, 24,30 and 36 months after randomization, and adverse events will be recorded.In addition,biological samples will be collected for mechanism exploration studies. DiscussionThis will be the first clinical trial to evaluate the disease-free survival (DFS) and improvements in quality of life in patients of stage IIIb and IIIc gastric cancer receiving TCMCM, which may be used to formulate a standardized TCMCM plan. We are also performing this trial to assess the feasibility of a larger-scale clinical trial in the future. Trail registrationClinicalTrials.gov，NCT03607656. Registered on 1 July 2018.The final protocol version was V1.1.