Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

236

Study ID:

NCT00096356

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 29 Locations for this study

See Locations Near You

CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Helen F. Graham Cancer Center at Christiana Hospital
Newark Delaware, 19713, United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia, 20060, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
MBCCOP - JHS Hospital of Cook County
Chicago Illinois, 60612, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
CCOP - Beaumont
Royal Oak Michigan, 48073, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
CCOP - Heartland Research Consortium
Saint Louis Missouri, 63131, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65804, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington North Carolina, 27216, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro North Carolina, 27534, United States
Pardee Memorial Hospital
Hendersonville North Carolina, 28791, United States
High Point Regional Hospital
High Point North Carolina, 27261, United States
Caldwell Memorial Hospital
Lenoir North Carolina, 28645, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Cancer Centers of the Carolinas - Eastside
Greenville South Carolina, 29615, United States
South Carolina Cancer Specialists, PA at Hilton Head Medical Center
Hilton Head Island South Carolina, 29925, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville Virginia, 24115, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

236

Study ID:

NCT00096356

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider