Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
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.
Dietary Supplement: coenzyme Q10
Dietary Supplement: vitamin E
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Caner Patients|
- Effects of coenzyme Q10 by POMS-F at baseline, 8 weeks, 16 weeks, and 24 weeks
- Effects of coenzyme Q10 on quality of life as measured by FACT-B with FACIT-F subscale, patient self-rating of fatigue, CES-D short-form, MOS social support; baseline, 8 weeks, 16 weeks, and 24 weeks
- Effects of coenzyme Q10 on depression as measured by FACT-B with FACIT-F subscale, patient self-rating of fatigue, CES-D short-form, MOS social support; baseline, 8 weeks, 16 weeks, and 24 weeks
|Study Start Date:||August 2004|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.
- 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.