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Clinical Trial
. 2024 Oct 28;14(1):25690.
doi: 10.1038/s41598-024-76627-z.

Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer

Wen-Chi Shen  1   2 , Shin-Cheh Chen  2   3 , Cheng-Hsu Wang  2   4 , Chao-Ming Hung  5   6 , Meng-Ting Peng  1 , Chien-Ting Liu  2   7 , Yueh-Shih Chang  4   8 , Wen-Ling Kuo  2   3   9 , Hsu-Huan Chou  2   3 , Kun-Yun Yeh  2   4 , Tsung-Han Wu  2   4 , Chun-Feng Wu  2   4 , Pei-Hung Chang  2   4 , Yen-Min Huang  2   4 , Chi-Chang Yu  2   3 , Chun-Hui Lee  2   10 , Kun-Ming Rau  11   12
Affiliations
Clinical Trial

Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer

Wen-Chi Shen et al. Sci Rep. .

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.

Keywords: Astragalus polysaccharides; Adjuvant chemotherapy; Breast cancer; Cancer-related fatigue; Chemotherapy-related fatigue.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Flow chart of screening, treatment, and follow-up.
Figure 2
Figure 2
Randomization, treatment assignments, and follow-up. ITT intention-to-treat; PG2, Astragalus Polysaccharides; PP, per-protocol.
Figure 3
Figure 3
Time-dependent change in BFI fatigue scores and mean EORTC QLQ-C30 Global health status/QoL scores in the two groups at the end of cycle 4 for the ITT population. (a) Fatigue global score (b) Fatigue intensity (c) Global health status/QoL. BFI, brief fatigue inventory; PG2, Astragalus Polysaccharides. *represents the statistical significance between the groups at each time point.
Figure 4
Figure 4
Time-dependent change in BFI fatigue scores in the two groups at the end of cycle 4 for the premenopausal ITT population. BFI, brief fatigue inventory, PG2, Astragalus polysaccharides. *represents the statistical significance between the groups at each time point.
Figure 5
Figure 5
Time-dependent in EORTC QLQ-C30 & Br23 scores in the two groups at the end of cycle 4 for the premenopausal ITT population. (a) Global health status/QoL (b) Future perspective (c) Fatigue (d) Insomnia. PG2, Astragalus polysaccharides. *represents the statistical significance between the groups at each time point.
See this image and copyright information in PMC

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