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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle
500 ml saline, 3 days via i.v. infusion per chemotherapy cycle
Epirubicin plus Cyclophosphamide every 21 days
E-Da Cancer Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Kaohsiung Branch
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Lovers Lake branch
Keelung, Taiwan
Chang Gung Memorial Hospital, Taipei Branch
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan
Change in chemotherapy-related fatigue by brief fatigue Inventory
Time frame: through 4 chemotherapy cycles (each cycle is 21 days)
Incidence of Grade 3/4 neutropenia
Time frame: through 4 chemotherapy cycles (each cycle is 21 days)
Incidence of other Grade 3/4 Hematologic Toxicities
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Chemotherapy Dose Reductions
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Days of chemotherapy delay
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Cumulative Doses of G-CSF consumption
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
Health-related Quality of Life by EORTC QLQ-C30 & Br23
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
ECOG
Time frame: through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days)
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