Department of Endocrinology, Affiliated Hospital of Jiangnan University, Wuxi, 214122, China.
State Key Laboratory of Food Science and Technology, School of Food Science and Technology, Jiangnan University, Wuxi, 214122, China.
Trials. 2023 Apr 12;24(1):268. doi: 10.1186/s13063-023-07137-y.
The prevalence of colorectal cancer (CRC) worldwide is a huge challenge to human health. Primary tumor locations found to impact prognosis and response to therapy. The important role of gut microbiota in the progression and treatment of CRC has led to many attempts of alleviating chemotherapy-induced adverse effects using microecologics. However, the underlying mechanism of the difference in the prognosis of different primary tumor locations and the synergistic effect of prebiotics on chemotherapy need to be further elucidated. This study aims to explore the differences in tumor microbiota and examine the effectiveness of xylooligosaccharides (XOS) on gut microbiota, adverse effects, and bioavailability of chemotherapy drugs in CRC patients at different primary tumor locations.
This is a double-blinded, randomized, parallel controlled clinical trial. Participants with left-sided CRC (LSCRC, n = 50) and right-sided CC (RSCC, n = 50) will randomly allocated to prebiotic group (n = 25) or control group (n = 25) and will receive either a daily XOS (3 g/day) or placebo, respectively, for 12 weeks. The primary outcomes will be the differences in the mucosa microbiota composition at different tumor locations and differences in gut microbiota composition, adverse effects, and blood concentration of capecitabine posttreatment. The secondary outcomes will include other blood indicators, short-chain fatty acids (SCFAs) concentration, quality of life, and mental health.
This study will reveal the potential benefits of prebiotic for improving the gut microbiota composition, alleviating the adverse effects, and improving the efficacy of chemotherapy in patients with CRC. In addition, this study will provide data on the different distribution of tumor microbiota and the different changes of gut microbiota during treatment in LSCRC and RSCC, which may provide novel insights into personalized cancer treatment strategies based on primary tumor locations and gut microbiota in the future.
Chinese Clinical Trial Registry ( www.chictr.org.cn ): ChiCTR2100046237. Registered on 12 May 2021.
结直肠癌（CRC）在全球的流行是对人类健康的巨大挑战。原发肿瘤部位被发现影响预后和对治疗的反应。肠道微生物群在 CRC 的发生和治疗中的重要作用导致了许多尝试使用微生态制剂来减轻化疗引起的不良反应。然而，不同原发肿瘤部位预后差异的潜在机制以及益生元对化疗的协同作用仍需进一步阐明。本研究旨在探讨肿瘤微生物群的差异，并研究木寡糖（XOS）对不同原发肿瘤部位 CRC 患者肠道微生物群、不良反应和化疗药物生物利用度的影响。
这是一项双盲、随机、平行对照的临床试验。左半结肠癌（LSCRC，n=50）和右半结肠癌（RSCC，n=50）患者将被随机分为益生元组（n=25）或对照组（n=25），分别接受每日 XOS（3g/天）或安慰剂治疗，共 12 周。主要结局将是不同肿瘤部位黏膜微生物群组成的差异以及治疗后肠道微生物群组成、不良反应和卡培他滨血药浓度的差异。次要结局将包括其他血液指标、短链脂肪酸（SCFAs）浓度、生活质量和心理健康。
本研究将揭示益生元改善 CRC 患者肠道微生物群组成、减轻不良反应和提高化疗疗效的潜在益处。此外，本研究将提供关于 LSCRC 和 RSCC 中肿瘤微生物群不同分布和治疗过程中肠道微生物群不同变化的数据，这可能为基于原发肿瘤部位和肠道微生物群的个性化癌症治疗策略提供新的见解。
中国临床试验注册中心（www.chictr.org.cn）：ChiCTR2100046237。于 2021 年 5 月 12 日注册。
