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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00096356
First received: November 9, 2004
Last updated: December 17, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Breast Cancer
Fatigue
Dietary Supplement: CoQ10 & Vitamin E
Dietary Supplement: Placebo & Vitamin E
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Wake Forest NCORP Research Base:

Primary Outcome Measures:
  • Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.


Secondary Outcome Measures:
  • Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 236
Study Start Date: August 2004
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096356

  Show 31 Study Locations
Sponsors and Collaborators
Wake Forest NCORP Research Base
Investigators
Principal Investigator: Glenn J. Lesser, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided by Wake Forest NCORP Research Base

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier: NCT00096356     History of Changes
Other Study ID Numbers: CCCWFU-97202, U10CA081851
Study First Received: November 9, 2004
Results First Received: September 8, 2014
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest NCORP Research Base:
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:
Breast Neoplasms
Fatigue
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases
Alpha-Tocopherol
Coenzyme Q10
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on July 01, 2015