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: Randomized clinical trial to study the effectiveness of coenzyme Q10 in relieving treatment-related fatigue in women who have breast cancer.

Condition	Treatment or Intervention
Breast Cancer Fatigue	Drug: coenzyme Q10  Drug: vitamin E  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: fatigue assessment/management  Procedure: nutritional supplementation  Procedure: supportive care/therapy

Further Study Details: 

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 101-202 patients (51-101 per treatment arm) will be accrued for this study within 6-12 months.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of primary breast cancer
• Planned adjuvant chemotherapy
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• Any age

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin at least 11 g/dL

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No uncontrolled hypertension or hypertension requiring medication

Other

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• Cholesterol at least 160 mg/dL
• No recent significant weight loss (more than 5% of body weight within the past 3 months)
• No diabetes

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent epoetin alfa for fatigue

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• No concurrent corticosteroids for fatigue
• Concurrent corticosteroids for antiemetic prophylaxis allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent amphetamines (e.g., methylphenidate) for fatigue
• No concurrent anticoagulant therapy
• No concurrent statin therapy
• No other concurrent supplements containing vitamin E or coenzyme Q_10

Louisiana
      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
North Carolina
      Alamance Cancer Center, Burlington,  North Carolina,  27216,  United States; Recruiting
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting

Study chairs or principal investigators

Glenn J. Lesser, MD,  Principal Investigator,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000331829; CCCWFU-97202; NCT00096356
Record last reviewed:  October 2004
Last Updated:  February 4, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096356
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08