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

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ClinicalTrials.gov Identifier: NCT00096356

Recruitment Status : Completed

First Posted : November 9, 2004

Results First Posted : December 29, 2014

Last Update Posted : September 29, 2021

View this study on Beta.ClinicalTrials.gov

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

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

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

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

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

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