NCT00176540终止不适用
A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer.
PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.
详细描述
OBJECTIVES:
Primary
- Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue.
Secondary
- Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of malignancy
- •Must be undergoing active treatment for malignancy which may include hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate), but not radiotherapy alone
- •Fatigue score ≥ 4 on a verbal analogue scale of 0 to 10
- •No untreated cancer-related anemia
- •PATIENT CHARACTERISTICS:
- •Hemoglobin > 10 g/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to swallow pills
- •No known allergy to dextromethorphan hydrobromide
- •No patients known to be phenotypically poor metabolizers of CYP2D6
- •No untreated hypothyroidism
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior single-dose inhibitors (e.g., ranitidine or cimetidine) for hypersensitivity prophylaxis allowed
- •Erythropoietic growth factor therapy of > 8 weeks duration allowed
- •No concurrent CYP2D6 inducers or inhibitors
- •No concurrent monoamine oxidase inhibitors
- •No other concurrent medications containing dextromethorphan hydrobromide
- •No concurrent over-the-counter medication, herbal product, vitamin, food supplement, or any other type of special product unless permission to continue use is obtained from the Principal Investigator
- •No other concurrent anticancer investigational agents or therapies
排除标准
- 未提供
结局指标
主要结局
Efficacy
次要结局
- Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
研究者
研究点 (2)
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