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Open Access 01-12-2022 | Metastasis | Study protocol

Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial

Authors: Zhaoyan Li, Guangtao Zhang, Nida Cao, Jingjuan Xu, Jiahuan Dong, Jia Li, Xiaohong Zhu, Yan Xu, Chen Han, Rui Wang, Xiang Xia, Gang Zhao, Xiangkun Huan, Jin Fan, Aiguang Zhao

Published in: Trials | Issue 1/2022

Abstract

Background

Metastasis and/or recurrence can decrease the survival time of gastric cancer patients undergoing radical operation. Among them, those with stage IIIb and IIIc are especially at a high risk of metastasis and recurrence. The traditional Chinese medicine collaborative model (TCMCM) has been used in the treatment of cancer; however, its effects have not been systematically evaluated. This study is designed to evaluate whether TCMCM can decrease adverse effects after chemotherapy and reduce the recurrence and metastasis of stage IIIb and IIIc gastric cancer.

Methods/design

This prospective, multicenter, randomized, open-label trial will recruit 260 patients with stage IIIb and IIIc gastric cancer who undergo radical surgery for D2 lymphadenectomy. The patients will be randomly assigned to receive usual adjuvant chemotherapy and TCMCM (intervention group) in a 1:1 ratio. Patients in the intervention group will receive an oral traditional Chinese formula, auricular acupressure, and acupoint therapy. All participants will receive usual adjuvant chemotherapy. The primary outcome is a 3-year disease-free survival rate. Secondary outcomes include quality of life, side effects caused by chemotherapy, and safety-related measures. Assessments will be performed during the screening period, at 4 and 8 cycles after adjuvant chemotherapy, and 9, 12, 18, 24, 30, and 36 months after randomization. Adverse events will be recorded. In addition, biological samples will be collected for mechanism analysis.

Discussion

This will be the first clinical trial to evaluate the effects of TCMCM on disease-free survival (DFS) and quality of life in patients with stage IIIb and IIIc gastric cancer. Our results may be used to standardize TCMCM. We will also perform a larger-scale clinical trial in the future.

Trial registration

ClinicalTrials.govNCT03607656. Registered on 1 July 2018. The final protocol version is V1.1.

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Title: Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial
Authors: Zhaoyan Li
Guangtao Zhang
Nida Cao
Jingjuan Xu
Jiahuan Dong
Jia Li
Xiaohong Zhu
Yan Xu
Chen Han
Rui Wang
Xiang Xia
Gang Zhao
Xiangkun Huan
Jin Fan
Aiguang Zhao
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Metastasis
Gastric Cancer
Gastric Cancer
Cytostatic Therapy
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06013-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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