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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096356
First received: November 9, 2004
Last updated: July 3, 2010
Last verified: December 2008
  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
Breast Cancer
Fatigue
Dietary Supplement: coenzyme Q10
Dietary Supplement: vitamin E

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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 Caner Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Effects of coenzyme Q10 by POMS-F at baseline, 8 weeks, 16 weeks, and 24 weeks

Secondary Outcome Measures:
  • Effects of coenzyme Q10 on quality of life as measured by FACT-B with FACIT-F subscale, patient self-rating of fatigue, CES-D short-form, MOS social support; baseline, 8 weeks, 16 weeks, and 24 weeks
  • Effects of coenzyme Q10 on depression as measured by FACT-B with FACIT-F subscale, patient self-rating of fatigue, CES-D short-form, MOS social support; baseline, 8 weeks, 16 weeks, and 24 weeks

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of primary breast cancer
  • Planned adjuvant chemotherapy

    • No neoadjuvant chemotherapy
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Any age

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin at least 11 g/dL (supportive measures [i.e., epoetin alfa, transfusion, or iron therapy] allowed)

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2.5 times ULN

Renal

  • Not specified

Cardiovascular

  • No uncontrolled hypertension or hypertension requiring medication

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Cholesterol at least 160 mg/dL
  • No recent involuntary weight loss (more than 5% of body weight within the past 3 months)
  • No diabetes
  • No uncontrolled thyroid dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Hematopoietic

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • No concurrent corticosteroids for fatigue

    • Concurrent corticosteroids for pre-chemotherapy antiemetic prophylaxis allowed

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent amphetamines (e.g., methylphenidate or modafinil) or other stimulants for fatigue
  • No concurrent anticoagulant therapy except to maintain catheter patency
  • No concurrent statin therapy, including, but not limited to, any of the following medications:

    • Atorvastatin
    • Cerivastatin
    • Fluvastatin
    • Mevastatin
    • Pravastatin
    • Rosuvastatin
    • Simvastatin
  • No other concurrent supplements containing vitamin E or coenzyme Q_10
  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 School of Medicine
Investigators
Principal Investigator: Glenn J. Lesser, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00096356     History of Changes
Other Study ID Numbers: CDR0000331829, CCCWFU-97202, WFU 97202
Study First Received: November 9, 2004
Last Updated: July 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Coenzyme Q10
Ubiquinone
Vitamin E
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on August 20, 2014