The Effects of Compound Herbal Formula(TPE-1) for Leukopenia and Cancer-related Fatigue in Breast Cancer Patients With Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the % change of white blood cell(WBC) count
研究概览
简要总结
Many breast cancer patients will taking Chinese herbal medicine during receiving radiotherapy. The investigators conducted the pilot study showing Compound Herbal Formula (TPE-1) have the effect of improving the fatigue and leukopenia during radiotherapy. So the investigators designed this double blind and controlled trial to evaluate whether TPE-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. From our initial observation for 2 years, TPE-1 is safety. The study is also designed to evaluate the safety when patients taking this formula.
详细描述
TPE-1 is designed according to TCM concept. It is not anti-cancer directly, it is enhancing the Qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. Many Chinese population will seeking Chinese herbal medicine under the same condition.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer
- •age between 18 to 70 yrs
- •finished chemotherapy (adriamycin ), will receiving radiotherapy
- •Chinese population
- •KP$ between 40-100
- •ECOG < 2
- •WBC >4X10(9)／L and Hb > 10g/dl
- •Assigned informed concent.
排除标准
- •receiving operation during 14 days
- •blood transfusion during one month.
- •ALT >100mg/dL
- •Creatinine >2.0mg/dL
- •Total bilirubin >2.0mg/dL
- •Infection
- •prolation
- •Taking anti-seizure , psychological drugs or any drugs not suitable patients
- •AIDS or any disease diagnosed by physician and not suitable patients.
研究组 & 干预措施
herbal A
dilute of (TPE-1) decoction.
干预措施: Chinese herbal medicine decoction (Drug)
herbal B
TPE-1 decoction (100 ml)
干预措施: Chinese herbal medicine decoction (Drug)
结局指标
主要结局
the % change of white blood cell(WBC) count
时间窗: 6 weeks
WBC will be checked before taking TPE ans after taking TPE-1.
次要结局
- Hemoglobin (Hb)(6 weeks)
研究者
Chung-Hua Hsu
vice superintendent
Taipei City Hospital