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NCT Number: NCT00096356

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

CCOP - Western Regional, Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoQ10 & Vitamin E

Dietary Supplement

Other names: CoenzymeQ10

Placebo & Vitamin E

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: CoQ10

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Nov 9, 2004
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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