A recent study published in Scientific Reports has demonstrated the potential of Astragalus polysaccharides (PG2) to alleviate chemotherapy-induced fatigue (CIF) in patients with stage II/III early breast cancer (EBC) undergoing adjuvant chemotherapy. The double-blind, randomized, placebo-controlled trial provides evidence for the efficacy and safety of PG2 as a complementary treatment to improve the quality of life for these patients.
Study Design and Methodology
The study enrolled patients scheduled for anthracycline-based adjuvant chemotherapy (EC regimen) and randomized them to receive either PG2 or a placebo. PG2, an active fraction of highly purified Astragalus polysaccharides derived from Astragalus membranaceus, was administered intravenously at a dose of 500 mg on days 1, 3, and 8 of each chemotherapy cycle. The primary endpoint was the change in fatigue severity, assessed using the Brief Fatigue Inventory-Taiwan (BFI-Taiwan). Secondary endpoints included overall quality of life, measured by the EORTC QLQ-C30 & BR23 questionnaires.
Key Findings
The results indicated that PG2 significantly reduced fatigue severity compared to the placebo group. Furthermore, patients receiving PG2 reported improvements in various aspects of quality of life, including physical, emotional, and social functioning. The study also monitored adverse events (AEs) and found that PG2 was well-tolerated, with no significant differences in the incidence of AEs between the treatment and placebo groups.
Clinical Implications
Chemotherapy-induced fatigue is a common and debilitating side effect that can significantly impact patients' adherence to treatment and overall well-being. The current treatment landscape for CIF is limited, with few effective and well-tolerated options. This study suggests that PG2 could be a valuable addition to the supportive care regimen for breast cancer patients undergoing chemotherapy.
Expert Commentary
"These findings are encouraging and suggest that Astragalus polysaccharides may offer a safe and effective way to manage chemotherapy-induced fatigue," said Dr. [Name], lead investigator of the study. "Further research is needed to confirm these results and to explore the optimal dosing and administration of PG2 for CIF."
Trial Details
The trial, registered at ClinicalTrials.gov with the number NCT03314805, included patients with stage II/III EBC scheduled to receive an adjuvant EC-upfront regimen. Key inclusion criteria were age above 20 years, adequate bone marrow function, and normal liver and kidney function. Exclusion criteria included pregnancy, chronic insomnia, uncontrolled active infection, and a history of other malignancies. The study adhered to the principles outlined in the Declaration of Helsinki and was approved by the Institutional Review Board of all participating hospitals.
