Status:
COMPLETED
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Fatigue
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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 s...
Detailed Description
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 li...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 27 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2009
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00096356
Start Date
August 27 2004
End Date
August 31 2009
Last Update
September 29 2021
Active Locations (31)
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1
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
2
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
3
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
4
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States, 19713