Division of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan.
College of Medicine, Chang Gung University, Taoyuan City, Taiwan.
Sci Rep. 2024 Oct 28;14(1):25690. doi: 10.1038/s41598-024-76627-z.
This study aimed to evaluate the effect of Astragalus polysaccharides (PG2) on reducing chemotherapy-induced fatigue (CIF) and toxicity, thereby encouraging compliance to chemotherapy. This was a randomized, placebo-controlled, phase 2 study. Patients with stage II/III early breast cancer planning to undergo adjuvant anthracycline-based chemotherapy were randomly assigned to receive PG2 500 mg or placebo on days 1, 3, and 8 every 21 days. The fatigue global score (FGS) was assessed using the brief fatigue inventory (BFI)-Taiwan. The Breast Cancer-Specific Module of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 evaluated the health-related quality of life during the first four cycles of adjuvant chemotherapy. Overall, 66 eligible patients were equally randomized into the PG2 and placebo groups between March 01, 2018, and March 09, 2021. The mean change in the FGS and fatigue intensity did not significantly differ between both groups. However, the FGS and fatigue intensity were less aggravated in the first four cycles in the premenopausal-PG2 group than in the placebo group. Our study concluded PG2 combined with adjuvant chemotherapy can reduce CIF, insomnia, the negative effect on future perspectives, and improve global health status, especially for premenopausal patients with breast cancer. Trial registration number: NCT03314805 registered on 19/10/2017.
本研究旨在评估黄芪多糖(PG2)对减轻化疗引起的疲劳(CIF)和毒性的影响,从而鼓励患者接受化疗。这是一项随机、安慰剂对照、2 期研究。计划接受辅助蒽环类化疗的 II/III 期早期乳腺癌患者被随机分配在第 1、3 和 8 天,每 21 天接受 PG2 500mg 或安慰剂治疗。疲劳总体评分(FGS)使用简短疲劳量表(BFI)-台湾进行评估。欧洲癌症研究与治疗组织癌症生存质量核心问卷-乳腺癌模块 30(EORTC QLQ-C30)评估了辅助化疗前四个周期期间的健康相关生活质量。总体而言,66 名符合条件的患者于 2018 年 3 月 1 日至 2021 年 3 月 9 日之间被平均随机分配到 PG2 和安慰剂组。两组之间 FGS 和疲劳强度的平均变化没有显著差异。然而,PG2 组在四个周期内的 FGS 和疲劳强度在前四个周期内比安慰剂组的加重程度较轻。我们的研究得出结论,PG2 联合辅助化疗可减轻 CIF、失眠、对未来前景的负面影响,并改善全球健康状况,尤其是对乳腺癌的绝经前患者。试验注册号:NCT03314805,于 2017 年 10 月 19 日注册。