A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Caner Patients
- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with
- 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
PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Effects of coenzyme Q10 by POMS-F at baseline, 8 weeks, 16 weeks, and 24 weeks
Glenn J. Lesser, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|CCOP - Santa Rosa Memorial Hospital||Santa Rosa, California 95403|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Western Regional, Arizona||Phoenix, Arizona 85006-2726|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|CCOP - St. Louis-Cape Girardeau||Saint Louis, Missouri 63141|
|CCOP - Beaumont||Royal Oak, Michigan 48073-6769|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|MBCCOP - Howard University Cancer Center||Washington, District of Columbia 20060|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Missouri Baptist Cancer Center||St. Louis, Missouri 63131|
|Pardee Memorial Hospital||Hendersonville, North Carolina 28791|
|Cancer Centers of the Carolinas - Eastside||Greenville, South Carolina 29601|
|High Point Regional Hospital||High Point, North Carolina 27261|
|Alamance Cancer Center at Alamance Regional Medical Center||Burlington, North Carolina 27216|
|Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County||Martinsville, Virginia 24115|
|MBCCOP - JHS Hospital of Cook County||Chicago, Illinois 60612|
|Caldwell Memorial Hospital||Lenoir, North Carolina 28645|
|Southeastern Medical Oncology Center - Goldsboro||Goldsboro, North Carolina 27534|
|Helen F. Graham Cancer Center at Christiana Hospital||Newark, Delaware 19718|
|CCOP - Heartland Research Consortium||St. Louis, Missouri 63131|
|South Carolina Cancer Specialists, PA at Hilton Head Medical Center||Hilton Head Island, South Carolina 29925|