| Autor: |
Xu Zhou, Dong-mei Yan, Wei-feng Zhu, Wen-jun Liu, He-yun Nie, Sheng Xu, Yi-ping Jiang, Kun-he Zhang, Ying Fu, Yi-ye Wan, Xin-yu Yu, Hong Li, Xin Sun, Xiao-fan Chen |
| Jazyk: |
angličtina |
| Rok vydání: |
2019 |
| Předmět: |
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| Zdroj: |
Trials, Vol 20, Iss 1, Pp 1-8 (2019) |
| Druh dokumentu: |
article |
| ISSN: |
1745-6215 |
| DOI: |
10.1186/s13063-019-3429-x |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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