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

Phase 1

Completed

Conditions: Fatigue
Breast Cancer

Interventions: Dietary Supplement: Placebo & Vitamin E
Dietary Supplement: CoQ10 & Vitamin E

Registration Number: NCT00096356

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 236

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Placebo & Vitamin E	Placebo & Vitamin E	Placebo-Vitamin E 100 mg/day in 3 doses
Arm 1 - CoQ10 & Vitamin E	CoQ10 & Vitamin E	CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
Arm 1 - CoQ10 & Vitamin E	Placebo & Vitamin E	CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization	24 weeks	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.
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization	24 weeks	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.

Trial Locations

Locations (31): MBCCOP - JHS Hospital of Cook County
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Chicago, Illinois, United States
CCOP - Central Illinois
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Decatur, Illinois, United States
CCOP - Beaumont
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Royal Oak, Michigan, United States
CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States
CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, United States
CCOP - Columbus
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Columbus, Ohio, United States
CCOP - Michigan Cancer Research Consortium
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Ann Arbor, Michigan, United States
CCOP - Western Regional, Arizona
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Phoenix, Arizona, United States
CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States
Helen F. Graham Cancer Center at Christiana Hospital
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Newark, Delaware, United States
CCOP - Mount Sinai Medical Center
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Miami Beach, Florida, United States
CCOP - Christiana Care Health Services
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Newark, Delaware, United States
CCOP - Santa Rosa Memorial Hospital
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Santa Rosa, California, United States
MBCCOP - Howard University Cancer Center
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Washington, District of Columbia, United States
CCOP - Cedar Rapids Oncology Project
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Cedar Rapids, Iowa, United States
CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, United States
MBCCOP - LSU Health Sciences Center
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New Orleans, Louisiana, United States
CCOP - Heartland Research Consortium
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Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
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Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, United States
Alamance Cancer Center at Alamance Regional Medical Center
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Burlington, North Carolina, United States
Southeastern Medical Oncology Center - Goldsboro
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Goldsboro, North Carolina, United States
CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, United States
Pardee Memorial Hospital
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Hendersonville, North Carolina, United States
High Point Regional Hospital
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High Point, North Carolina, United States
Caldwell Memorial Hospital
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Lenoir, North Carolina, United States
Cancer Centers of the Carolinas - Eastside
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Greenville, South Carolina, United States
South Carolina Cancer Specialists, PA at Hilton Head Medical Center
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Hilton Head Island, South Carolina, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
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Martinsville, Virginia, United States
Danville Regional Medical Center
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Danville, Virginia, United States