Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Trials

Kun-he Zhang¹  Yi-ping Jiang²  Ying Fu³  Xin Sun⁴  Xu Zhou⁴  Wei-feng Zhu⁴  Dong-mei Yan⁴  Xiao-fan Chen⁴  Sheng Xu⁴  Hong Li⁴  He-yun Nie⁴  Xin-yu Yu⁴  Wen-jun Liu⁵  Yi-ye Wan⁶ 

[1] Department of Gastroenterology, First Affiliated Hospital of Nanchang University;Department of Spleen, Stomach, Liver and Gallbladder Diseases, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine;Department of Traditional Chinese Medicine, Second Affiliated Hospital of Nanchang University;Evidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine;School of Food Science and Engineering, Inner Mongolia Agricultural University;Third Department of Oncology, Jiangxi Provincial Cancer Hospital;

关键词: Hou Gu Mi Xi;    Randomized controlled trial;    Traditional Chinese medicine;    Gastric cancer;    Radical gastrectomy;    Spleen qi deficiency;   

DOI  :  10.1186/s13063-019-3429-x

来源: DOAJ

【 摘 要 】

Abstract Background Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM formula for SQD. This study aims to evaluate the efficacy and safety of HGMX in patients with SQD who have undergone radical gastrectomy for gastric cancer. Methods and design This study is a multicenter, randomized, double-blind, placebo-controlled trial. One hundred thirty patients with SQD who have undergone radical gastrectomy for gastric cancer will be assigned to receive either HGMX or placebo for 2 years. The main outcome will be changes in SQD symptoms assessed by the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale. The secondary outcomes will be changes in quality of life assessed by the Short Form 36 scale, performance status as assessed by the Eastern Cooperative Oncology Group Performance Status scale, body weight, and body mass index. Progression-free survival will also be assessed as a secondary outcome. Adverse events (AEs), severe AEs, and study withdrawal due to AEs will be recorded to evaluate the safety of HGMX. Discussion The results of this trial will provide initial evidence for the use of HGMX as an alternative and complementary intervention to manage chronic postoperative complications in patients who have undergone radical gastrectomy for gastric cancer. Trial registration ClinicalTrials.gov, NCT03025152. Registered on 17 January 2017.

【 授权许可】

Unknown