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Abstract
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.
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1 Linkou Chang Gung Memorial Hospital, Division of Hematology-Oncology, Department of Internal Medicine, Taoyuan City, Taiwan (GRID:grid.454211.7) (ISNI:0000 0004 1756 999X); Chang Gung University, College of Medicine, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922)
2 Chang Gung Memorial Hospital, Taipei, Department of General Surgery, Taipei City, Taiwan (GRID:grid.413801.f) (ISNI:0000 0001 0711 0593); Chang Gung University, College of Medicine, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922)
3 Chang Gung Memorial Hospital, Keelung, Division of Hematology-Oncology, Department of Internal Medicine, Keelung City, Taiwan (GRID:grid.413801.f) (ISNI:0000 0001 0711 0593); Chang Gung University, College of Medicine, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922)
4 E-Da Cancer Hospital, Department of General Surgery, Kaohsiung City, Taiwan (GRID:grid.414686.9) (ISNI:0000 0004 1797 2180); I-Shou University, School of Medicine, College of Medicine, Kaohsiung City, Taiwan (GRID:grid.411447.3) (ISNI:0000 0004 0637 1806)
5 Linkou Chang Gung Memorial Hospital, Division of Hematology-Oncology, Department of Internal Medicine, Taoyuan City, Taiwan (GRID:grid.454211.7) (ISNI:0000 0004 1756 999X)
6 Chang Gung Memorial Hospital, Kaohsiung, Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung City, Taiwan (GRID:grid.413801.f) (ISNI:0000 0001 0711 0593); Chang Gung University, College of Medicine, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922)
7 Chang Gung Memorial Hospital, Keelung, Division of Hematology-Oncology, Department of Internal Medicine, Keelung City, Taiwan (GRID:grid.413801.f) (ISNI:0000 0001 0711 0593); School of Traditional Chinese Medicine, College of Medicine, Chang Gung University, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922)
8 Chang Gung Memorial Hospital, Taipei, Department of General Surgery, Taipei City, Taiwan (GRID:grid.413801.f) (ISNI:0000 0001 0711 0593); Chang Gung University, College of Medicine, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922); National Tsing Hua University, Medical School, Hsin-Chu City, Taiwan (GRID:grid.38348.34) (ISNI:0000 0004 0532 0580)
9 Chang Gung Memorial Hospital, Keelung, Division of General Surgery, Department of Surgery, Keelung City, Taiwan (GRID:grid.413801.f) (ISNI:0000 0001 0711 0593); Chang Gung University, College of Medicine, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922)
10 E-Da Cancer Hospital, Department of Hematology-Oncology, Kaohsiung City, Taiwan (GRID:grid.145695.a); I-Shou University, School of Medicine, College of Medicine, Kaohsiung City, Taiwan (GRID:grid.411447.3) (ISNI:0000 0004 0637 1806)