NCT02858856Unknown不适用
Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Brief Fatigue Inventory change
研究概览
简要总结
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged over 18 years
- •patients who have histologically or cytologically confirmed breast tumor
- •patients who applicable AC(doxorubicin + cyclophosphamide)
- •ECOG score 0 to 2
排除标准
- •patient impossible to orally intake
- •patient with dementia, delirium and depression
- •patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
- •severe liver disability (3-fold the normal high range value for ALT, AST)
- •patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
- •severe systemic disease
- •use of other investigational products within the past 30 days
- •hypersensitivity to investigational product
- •others who are judged not to be appropriate to study
研究组 & 干预措施
A group
Experimental
Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks
干预措施: Sipjeondaebo-tang (Drug)
B group
Experimental
Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks
干预措施: Sipjeondaebo-tang (Drug)
结局指标
主要结局
Brief Fatigue Inventory change
时间窗: 6-11 week
次要结局
- EORTC-QLQ-C30 change(0-5 week, 6-11 week)
- EORTC-QLQ-BR23 change(0-5 week, 6-11 week)
研究者
Seong-Gyu Ko
Prof.
Kyunghee University Medical Center
研究点 (1)
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