NCT00555841终止2 期
Safety and Efficacy of Oral Acetyl-l-carnitine (ALC) in Non-anemic Potentially Curable Breast Cancer Subjects Undergoing Adjuvant Radiation Therapy Who Have Moderate to Severe Fatigue
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change of BFI as evaluated from Baseline to Final Visit
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy.
详细描述
The objective of this study is to evaluate the efficacy and safety of ALC in the treatment of non-anemic, breast cancer subjects who develop moderate or severe fatigue during adjuvant radiotherapy
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 0-III breast cancer in which adjuvant radiation is indicated;
- •Qualifying Brief Fatigue Inventory (BFI) score
排除标准
- •Medication to treat or manage fatigue and pain
- •Use of erythropoietin to control anemia
- •Clinical evidence of hypothyroidism or hyperthyroidism
研究组 & 干预措施
ALC
Experimental
I g three times daily
干预措施: ALC and Placebo (Drug)
Placebo
Placebo Comparator
1 g three times daily
干预措施: ALC and Placebo (Drug)
结局指标
主要结局
Change of BFI as evaluated from Baseline to Final Visit
时间窗: 16 weeks
次要结局
- Changes in Health-Related Quality of Life (HQoL) outcomes using Medical Outcomes Study Short Form Health Status Profile 12 items (MOS-SF 12(16 weeks)
研究者
研究点 (1)
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