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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-27

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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