Cancer-related Fatigue, Neutropenia, Malignant
Conditions
Keywords
astragalus polysaccharides, breast cancer, adjuvant chemotherapy
Brief 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.
Interventions
PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle
DRUGPlacebo
500 ml saline, 3 days via i.v. infusion per chemotherapy cycle
PROCEDUREEC Chemotherapy
Epirubicin plus Cyclophosphamide every 21 days
Sponsors
PhytoHealth Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in chemotherapy-related fatigue by brief fatigue Inventory | through 4 chemotherapy cycles (each cycle is 21 days) |
| Incidence of Grade 3/4 neutropenia | through 4 chemotherapy cycles (each cycle is 21 days) |
Secondary
| Measure | Time frame |
|---|---|
| Days of chemotherapy delay | through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) |
| Cumulative Doses of G-CSF consumption | through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) |
| Incidence of other Grade 3/4 Hematologic Toxicities | through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) |
| ECOG | through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) |
| Health-related Quality of Life by EORTC QLQ-C30 & Br23 | through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) |
| Chemotherapy Dose Reductions | through study completion, an average 6-8 chemotherapy cycles (each cycle is 21 days) |
Countries
Taiwan
Outcome results
None listed