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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breast Cancer Fatigue Dietary Supplement: CoQ10 & Vitamin E Dietary Supplement: Placebo & Vitamin E Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
Actual Study Start Date : August 27, 2004
Actual Primary Completion Date : August 31, 2009
Actual Study Completion Date : August 31, 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096356


Locations
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Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Glenn J. Lesser, MD Wake Forest University Health Sciences
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00096356    
Other Study ID Numbers: REBACCCWFU-97202
U10CA081851 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2004    Key Record Dates
Results First Posted: December 29, 2014
Last Update Posted: September 29, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vitamins
Vitamin E
 Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents