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

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.

Inclusion Criteria:

- Signed consent

- Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be
utilized to assist with maintaining Hgb levels

- Total cholesterol > 160mg/dL.

- Female with primary cancer diagnosis (breast)

- Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)

- KPS > 60

- Bilirubin < 1.5 x ULN

- SGOT < 2.5 x ULN

- SGPT < 2.5 x ULN

Exclusion Criteria:

- Recent involuntary weight loss (> 5% of body weight in the past 3 months)

- Statin therapy - current or planned during study. Below is a list of some commonly
used statin drugs.(Note: This is a helpful guide, not a complete list.)

- Atorvastatin (Lipitor)

- Cerivastatin

- Fluvastatin (Lescol)

- Lovastatin (Mevacor, Altocor, Advicor)

- Mevastatin

- Pravastatin (Pravachol)

- Rosuvastatin

- Simvastatin (Zocor)

- Current or planned use of the following medications for fatigue

- Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)

- Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil
(Provigil)

- Patients diagnosed with uncontrolled hypertension

- Breast cancer patients who are male

- Pregnant women are excluded from participation in this study. A Serum pregnancy test
is required within 1 week of registration if the patient is a woman of childbearing
potential.

- Anticoagulant therapy - current or planned during study (except for maintenance of
catheter patency)

- Patients with uncontrolled thyroid dysfunction