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

Study Overview
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Brief Summary
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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.

Official Title
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PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy

Conditions
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Cancer-related Fatigue, Neutropenia, Malignant

Intervention / Treatment
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* Drug: Astragalus polysaccharides 500 mg
* Drug: Placebo
* Procedure: EC Chemotherapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Placebo | Drug: Placebo<br>* 500 ml saline, 3 days via i.v. infusion per chemotherapy cycle<br>Procedure: EC Chemotherapy<br>* Epirubicin plus Cyclophosphamide every 21 days<br>|
| Experimental: Treatment<br>Astragalus polysaccharides 500 mg | Drug: Astragalus polysaccharides 500 mg<br>* PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle<br>* Other names: PG2 Lyo. Injection 500 mg;Procedure: EC Chemotherapy<br>* Epirubicin plus Cyclophosphamide every 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of other Grade 3/4 Hematologic Toxicities |  | 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) | 
| 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) | 
| Health-related Quality of Life by EORTC QLQ-C30 & Br23 |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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astragalus polysaccharides, breast cancer, adjuvant chemotherapy