Breast Cancer Clinical Trial
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
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 studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.
Full 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 life of these patients.
Determine the effect of this drug on depression in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). Patients are randomized to 1 of 2 treatment arms.
Arm I: Beginning on the first day of chemotherapy treatment, patients receive oral coenzyme Q_10 and oral vitamin E three times daily.
Arm II: Beginning on the first day of chemotherapy treatment, patients receive oral vitamin E and an oral placebo three times daily.
Treatment in both arms continues for 24 weeks in the absence of unacceptable toxicity.
Quality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks.
PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There are 29 Locations for this study
Phoenix Arizona, 85006, United States
Santa Rosa California, 95403, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20060, United States
Miami Beach Florida, 33140, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
South Bend Indiana, 46601, United States
Cedar Rapids Iowa, 52403, United States
New Orleans Louisiana, 70112, United States
Ann Arbor Michigan, 48106, United States
Royal Oak Michigan, 48073, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65804, United States
Burlington North Carolina, 27216, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
High Point North Carolina, 27261, United States
Lenoir North Carolina, 28645, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Columbus Ohio, 43215, United States
Greenville South Carolina, 29615, United States
Hilton Head Island South Carolina, 29925, United States
Spartanburg South Carolina, 29303, United States
Danville Virginia, 24541, United States
Martinsville Virginia, 24115, United States
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