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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096356
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : December 29, 2014
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE November 9, 2004
First Posted Date  ICMJE November 9, 2004
Results First Submitted Date  ICMJE September 8, 2014
Results First Posted Date  ICMJE December 29, 2014
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE August 27, 2004
Actual Primary Completion Date August 31, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Official Title  ICMJE A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Fatigue
Intervention  ICMJE
  • Dietary Supplement: CoQ10 & Vitamin E
    Other Name: CoenzymeQ10
  • Dietary Supplement: Placebo & Vitamin E
Study Arms  ICMJE
  • Active Comparator: Arm 1 - CoQ10 & Vitamin E
    CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
    Interventions:
    • Dietary Supplement: CoQ10 & Vitamin E
    • Dietary Supplement: Placebo & Vitamin E
  • Placebo Comparator: Arm 2 - Placebo & Vitamin E
    Placebo-Vitamin E 100 mg/day in 3 doses
    Intervention: Dietary Supplement: Placebo & Vitamin E
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2008)
236
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 31, 2009
Actual Primary Completion Date August 31, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00096356
Other Study ID Numbers  ICMJE REBACCCWFU-97202
U10CA081851 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wake Forest University Health Sciences
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Wake Forest University Health Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Glenn J. Lesser, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP