Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer

Completed · Phase 1 · Has a placebo group

Conditions studied: Breast Cancer, Fatigue

In brief

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.

Key facts

Study ID

NCT00096356

Run by

Wake Forest University Health Sciences

People needed

236

Starts

2004-08-27

Expected to finish

2009-08-31

Last updated by the study team

2021-09-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CCOP - Western Regional, Arizona — Phoenix, Arizona, United States
• CCOP - Santa Rosa Memorial Hospital — Santa Rosa, California, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Helen F. Graham Cancer Center at Christiana Hospital — Newark, Delaware, United States
• MBCCOP - Howard University Cancer Center — Washington D.C., District of Columbia, United States
• CCOP - Mount Sinai Medical Center — Miami Beach, Florida, United States
• MBCCOP - JHS Hospital of Cook County — Chicago, Illinois, United States
• CCOP - Central Illinois — Decatur, Illinois, United States
• CCOP - Northern Indiana CR Consortium — South Bend, Indiana, United States
• CCOP - Cedar Rapids Oncology Project — Cedar Rapids, Iowa, United States
• MBCCOP - LSU Health Sciences Center — New Orleans, Louisiana, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• CCOP - Beaumont — Royal Oak, Michigan, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• CCOP - Cancer Research for the Ozarks — Springfield, Missouri, United States
• CCOP - Heartland Research Consortium — St Louis, Missouri, United States
• Missouri Baptist Cancer Center — St Louis, Missouri, United States
• CCOP - St. Louis-Cape Girardeau — St Louis, Missouri, United States
• Alamance Cancer Center at Alamance Regional Medical Center — Burlington, North Carolina, United States
• Southeastern Medical Oncology Center - Goldsboro — Goldsboro, North Carolina, United States
• Pardee Memorial Hospital — Hendersonville, North Carolina, United States
• High Point Regional Hospital — High Point, North Carolina, United States
• Caldwell Memorial Hospital — Lenoir, North Carolina, United States
• CCOP - Southeast Cancer Control Consortium — Winston-Salem, North Carolina, United States
• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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