PG2 Treatment for Reduction of Chemotherapy-Induced Toxicity and Encouraging Compliance With Chemotherapy Among Stage II/III Breast Cancer Patients Receiving Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 10
- 主要终点
- Change in chemotherapy-related fatigue by brief fatigue Inventory
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Willing and able to complete quality of life questionnaires.
排除标准
- •Pregnancy or lactating women.
- •Baseline BFI score >
- •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).
研究组 & 干预措施
Control
Placebo
干预措施: Placebo (Drug)
Control
Placebo
干预措施: EC Chemotherapy (Procedure)
Treatment
Astragalus polysaccharides 500 mg
干预措施: Astragalus polysaccharides 500 mg (Drug)
Treatment
Astragalus polysaccharides 500 mg
干预措施: EC Chemotherapy (Procedure)
结局指标
主要结局
Change in chemotherapy-related fatigue by brief fatigue Inventory
时间窗: through 4 chemotherapy cycles (each cycle is 21 days)
Incidence of Grade 3/4 neutropenia
时间窗: through 4 chemotherapy cycles (each cycle is 21 days)
次要结局
- Days of chemotherapy delay(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))
- Chemotherapy Dose Reductions(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))