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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Placebo |
|
| Treatment | Experimental | Astragalus polysaccharides 500 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astragalus polysaccharides 500 mg | Drug | PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun-Ming Rau, MD | E-Da Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E-Da Cancer Hospital | Kaohsiung City | 824 | Taiwan | |||
| Chang Gung Memorial Hospital, Kaohsiung Branch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39465324 | Derived | Shen 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. |
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| ID | Term |
|---|---|
| C538171 | Acquired agranulocytosis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Placebo | Drug | 500 ml saline, 3 days via i.v. infusion per chemotherapy cycle |
|
| EC Chemotherapy | Procedure | Epirubicin plus Cyclophosphamide every 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) |
| Kaohsiung City |
| 833 |
| Taiwan |
| Chang Gung Memorial Hospital, Lovers Lake branch | Keelung | 204 | Taiwan |
| Chang Gung Memorial Hospital, Taipei Branch | Taipei | 105 | Taiwan |
| Chang Gung Memorial Hospital, Linkou Branch | Taoyuan City | 333 | Taiwan |
| D017437 |
| Skin and Connective Tissue Diseases |