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

Study Overview
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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.

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.

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

Conditions
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Breast Cancer, Fatigue

Intervention / Treatment
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* Dietary Supplement: CoQ10 & Vitamin E
* Dietary Supplement: Placebo & Vitamin E


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 - CoQ10 & Vitamin E<br>CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day. | Dietary Supplement: CoQ10 & Vitamin E<br> <br> * Other names: CoenzymeQ10;Dietary Supplement: Placebo & Vitamin E<br> <br> |
| Placebo Comparator: Arm 2 - Placebo & Vitamin E<br>Placebo-Vitamin E 100 mg/day in 3 doses | Dietary Supplement: Placebo & Vitamin E<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization | POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization | FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life. | 24 weeks | 
| Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization | CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer