Clinical trial · Interventional
PG2 Breast Cancer Evaluation in Adjuvant Medicine Study
PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
| Neutropenia, Malignant | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Astragalus polysaccharides 500 mg | Drug | — | UNRESOLVED |
| EC Chemotherapy | Procedure | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Placebo
- interventionNames
- Drug: Placebo
- Procedure: EC Chemotherapy
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Astragalus polysaccharides 500 mg
- interventionNames
- Drug: Astragalus polysaccharides 500 mg
- Procedure: EC Chemotherapy
Primary outcomes (2)
- measure
- Change in chemotherapy-related fatigue by brief fatigue Inventory
- timeFrame
- through 4 chemotherapy cycles (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDShen WC, Chen SC, Wang CH, Hung CM, Peng MT, Liu CT, Chang YS, Kuo WL, Chou HH, Yeh KY, Wu TH, Wu CF, Chang PH, Huang YM, Yu CC, Lee CH, Rau KM. Astragalus polysaccharides improve adjuvant chemotherapy-induced fatigue for patients with early breast cancer. Sci Rep. 2024 Oct 28;14(1):25690. doi: 10.1038/s41598-024-76627-z. PMID 39465324