NCT00096356已完成1 期
A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 62
- 主要终点
- Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
研究概览
简要总结
RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer.
PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.
Secondary
- Determine the effect of this drug on overall quality of life of these patients.
- Determine the effect of this drug on depression in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Signed consent
- •Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels
- •Total cholesterol > 160mg/dL.
- •Female with primary cancer diagnosis (breast)
- •Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)
- •KPS > 60
- •Bilirubin < 1.5 x ULN
- •SGOT < 2.5 x ULN
- •SGPT < 2.5 x ULN
排除标准
- •Recent involuntary weight loss (> 5% of body weight in the past 3 months)
- •Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)
- •Atorvastatin (Lipitor)
- •Cerivastatin
- •Fluvastatin (Lescol)
- •Lovastatin (Mevacor, Altocor, Advicor)
- •Mevastatin
- •Pravastatin (Pravachol)
- •Rosuvastatin
- •Simvastatin (Zocor)
- •Current or planned use of the following medications for fatigue
- •Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)
- •Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)
- •Patients diagnosed with uncontrolled hypertension
- •Breast cancer patients who are male
- •Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.
- •Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)
- •Patients with uncontrolled thyroid dysfunction
结局指标
主要结局
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
时间窗: 24 weeks
POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
次要结局
- Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization(24 weeks)
- Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization(24 weeks)
研究者
研究点 (62)
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