Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer (CoQ10)

September 28, 2021 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • CCOP - Christiana Care Health Services
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center at Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • MBCCOP - Howard University Cancer Center
    • Florida
      • Miami Beach, Florida, United States, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • MBCCOP - JHS Hospital of Cook County
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Indiana
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • CCOP - Cedar Rapids Oncology Project
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Royal Oak, Michigan, United States, 48073-6769
        • CCOP - Beaumont
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, United States, 63131
        • CCOP - Heartland Research Consortium
      • Springfield, Missouri, United States, 65804
        • CCOP - Cancer Research for the Ozarks
    • North Carolina
      • Burlington, North Carolina, United States, 27216
        • Alamance Cancer Center at Alamance Regional Medical Center
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center - Goldsboro
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
      • High Point, North Carolina, United States, 27261
        • High Point Regional Hospital
      • Lenoir, North Carolina, United States, 28645
        • Caldwell Memorial Hospital
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
      • Winston-Salem, North Carolina, United States, 27157-1030
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Eastside
      • Hilton Head Island, South Carolina, United States, 29925
        • South Carolina Cancer Specialists, PA at Hilton Head Medical Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, United States, 24115-4788
        • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 - CoQ10 & Vitamin E
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
Dietary supplement: CoQ10 & Vitamin E
Other Names:
  • CoenzymeQ10
Dietary supplement: Placebo & Vitamin E
Placebo Comparator: Arm 2 - Placebo & Vitamin E
Placebo-Vitamin E 100 mg/day in 3 doses
Dietary supplement: Placebo & Vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
Time Frame: 24 weeks
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
Time Frame: 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.
24 weeks
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
Time Frame: 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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Glenn J. Lesser, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2004

Primary Completion (Actual)

August 31, 2009

Study Completion (Actual)

August 31, 2009

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (Estimate)

November 9, 2004

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBACCCWFU-97202
  • U10CA081851 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on CoQ10 & Vitamin E

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe