NCT03314805

PG2 Treatment Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Completed Phase 2 Last updated 4 June 2025

What this trial tests

Phase 2 trial testing Astragalus polysaccharides 500 mg in Cancer-related Fatigue in 67 participants. Completed in 27 August 2021.

Timeline

1 March 2018

Primary endpoint
26 May 2021

27 August 2021

Quick facts

Lead sponsor	PhytoHealth Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	67
Start date	1 March 2018
Primary completion	26 May 2021
Estimated completion	27 August 2021
Sites	5 locations across Taiwan

Drugs / interventions tested

• Astragalus polysaccharides 500 mg — full drug profile →
• Placebo
• EC Chemotherapy — full drug profile →

Conditions studied

• Cancer-related Fatigue — all drugs for Cancer-related Fatigue →
• Neutropenia, Malignant — all drugs for Neutropenia, Malignant →

Sponsor

PhytoHealth Corporation — full company profile →

Who can join

20 and older, female only, with Cancer-related Fatigue or Neutropenia, Malignant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Adjuvant chemotherapy usually is recommended after surgery for breast cancer patients who are at significant risk for disseminated disease. Chemotherapy has been demonstrated to reduce the risk of breast cancer recurrence. Anthracycline-based regimens, including doxorubin or epilubicin, are the breast cancer adjuvant chemotherapy standards of care. Fatigue has also been identified as the most problem for breast cancer patients under adjuvant chemotherapy. In the current study, it is aimed to show that PG2 (astragalus polysaccharides) treatment among stage II/III breast patients under adjuvant EC regimen in reduction of chemotherapy-induced toxicity and encouraging compliance with chemotherapy.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Anticancer Mechanism of <i>Astragalus</i> Polysaccharide and Its Application in Cancer Immunotherapy.
   He Z, Liu X, Qin S, Yang Q, et al · · 2024 · cited 23× · PMID 38794206 · DOI 10.3390/ph17050636
2. Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer.
   Shen WC, Chen SC, Wang CH, Hung CM, et al · · 2024 · cited 13× · PMID 39465324 · DOI 10.1038/s41598-024-76627-z
3. Exploring the immunometabolic potential of Danggui Buxue Decoction for the treatment of IBD-related colorectal cancer.
   Zhang Y, Kang Q, He L, Chan KI, et al · · 2024 · cited 8× · PMID 39210410 · DOI 10.1186/s13020-024-00978-y
4. Metabolites of Astragalus membranaceus and their pro-apoptotic and cytotoxic activities: insights into targeted metabolic pathways.
   Liu J, Wang D, Ren N, Zhang L, et al · · 2025 · cited 1× · PMID 40949137 · DOI 10.3389/fphar.2025.1647958
5. Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer
   Shen W, Chen S, Wang C, Hung C, et al · · 2024 · DOI 10.21203/rs.3.rs-4336825/v1