Thoracic Oncology Ward, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Thorac Cancer. 2024 Jan;15(2):182-191. doi: 10.1111/1759-7714.15177. Epub 2023 Nov 29.
Chemotherapy is an important approach for lung cancer patients. The study was designed to evaluate the feasibility of the compound probiotic supplements in improving the quality of life for lung cancer patients undergoing chemotherapy.
This randomized, double-blind, placebo-controlled trial enrolled chemotherapy-naive patients with lung cancer who were scheduled to receive platinum-based doublet chemotherapy. All eligible patients were randomly administered (1:1) compound probiotic supplements (group BP-1) or placebo (group C) for two chemotherapy cycles. The EORTC QLQ C30 questionnaire scores were evaluated before the first, second, and third cycles of chemotherapy. The primary endpoint was the difference in the EROTC QLQ C30 questionnaire score between the two groups after two cycles of chemotherapy.
A total of 110 patients were recruited from March 2021 to January 2022. After undergoing two cycles of chemotherapy, group BP-1 were significantly better in various dimensions of the overall quality of life, role function, nausea and vomiting, appetite loss, constipation, and diarrhea relative to group C (76.90 ± 18.31 vs. 58.89 ± 17.17; 93.33 ± 11.58 vs. 85.93 ± 15.06; 0.00 ± 0.00 vs. 27.04 ± 29.15; 6.67 ± 13.53 vs. 22.22 ± 18.80; 0.95 ± 5.63 vs. 28.15 ± 22.42; 2.86 ± 9.47 vs. 15.56 ± 16.82; p < 0.05, respectively). The incidence of nausea and vomiting, appetite loss, constipation, and diarrhea in group BP-1 was significantly lower than in group C (0% vs. 71.43%, 16.67% vs. 57.14%, 2.38% vs. 63.27%, and 7.14% vs. 42.86%, respectively, p < 0.001).
Compound probiotic supplements can improve the quality of life and relieve chemotherapy-related gastrointestinal side effects for lung cancer patients receiving platinum-based doublet chemotherapy. (Chinese Clinical Trial Registry: ChiCTR1800019269).
化疗是肺癌患者的重要治疗方法。本研究旨在评估复方益生菌补充剂改善接受含铂双药化疗的肺癌患者生活质量的可行性。
这是一项随机、双盲、安慰剂对照的临床试验,纳入了计划接受含铂双药化疗的初治肺癌患者。所有符合条件的患者被随机(1:1)分配接受复方益生菌补充剂(BP-1 组)或安慰剂(C 组)治疗 2 个化疗周期。在第 1、2 和 3 个化疗周期前评估 EORTC QLQ C30 问卷评分。主要终点是化疗 2 个周期后两组 EORTC QLQ C30 问卷评分的差异。
2021 年 3 月至 2022 年 1 月期间共招募了 110 例患者。与 C 组相比,BP-1 组在化疗 2 个周期后整体生活质量、角色功能、恶心呕吐、食欲丧失、便秘和腹泻等各维度均显著改善(76.90 ± 18.31 分 vs. 58.89 ± 17.17 分;93.33 ± 11.58 分 vs. 85.93 ± 15.06 分;0.00 ± 0.00 分 vs. 27.04 ± 29.15 分;6.67 ± 13.53 分 vs. 22.22 ± 18.80 分;0.95 ± 5.63 分 vs. 28.15 ± 22.42 分;2.86 ± 9.47 分 vs. 15.56 ± 16.82 分;p<0.05)。BP-1 组恶心呕吐、食欲丧失、便秘和腹泻的发生率明显低于 C 组(0% vs. 71.43%,16.67% vs. 57.14%,2.38% vs. 63.27%,7.14% vs. 42.86%;p<0.001)。
复方益生菌补充剂可改善接受含铂双药化疗的肺癌患者的生活质量,减轻化疗相关胃肠道不良反应。(中国临床试验注册中心:ChiCTR1800019269)