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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PhytoHealth Corporation

Criteria

Inclusion Criteria:

• Women who are able to provide informed consent

• Age 20 years and older

• Diagnosis of stage II to III breast cancer

• Patients who had undergone surgery for breast cancer treatment.

• Planning to receive anthracycline -based adjuvant chemotherapy

• Have adequate bone marrow, liver, and renal function

• ECOG ≦1

• Willing and able to complete quality of life questionnaires.

Exclusion Criteria:

• Pregnancy or lactating women.

• Baseline BFI score >3.

• History of chronic fatigue syndrome, uncontrolled active infection, active cardiac disease, poor controlled hypertension or diabetes mellitus, any serious medical condition, psychiatric illness, and regular steroid therapy as determined by investigators.

• History of previous breast cancer or other malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer.

• Known severe allergy to Astragalus membranaceus or its mayor extracts (polysaccharides).