A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Caner Patients

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of primary breast cancer

- Planned adjuvant chemotherapy

- No neoadjuvant chemotherapy

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- Any age

Sex

- Female

Menopausal status

- Not specified

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin at least 11 g/dL (supportive measures [i.e., epoetin alfa, transfusion, or
iron therapy] allowed)

Hepatic

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT and SGPT less than 2.5 times ULN

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 involuntary weight loss (more than 5% of body weight within the past 3
months)

- No diabetes

- No uncontrolled thyroid dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Hematopoietic

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- No concurrent corticosteroids for fatigue

- Concurrent corticosteroids for pre-chemotherapy antiemetic prophylaxis allowed

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No concurrent amphetamines (e.g., methylphenidate or modafinil) or other stimulants
for fatigue

- No concurrent anticoagulant therapy except to maintain catheter patency

- No concurrent statin therapy, including, but not limited to, any of the following
medications:

- Atorvastatin

- Cerivastatin

- Fluvastatin

- Mevastatin

- Pravastatin

- Rosuvastatin

- Simvastatin

- No other concurrent supplements containing vitamin E or coenzyme Q_10