NCT00096356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Aug 2004

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2009

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

December 29, 2014

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

November 9, 2004

Results QC Date

September 8, 2014

Last Update Submit

September 28, 2021

Conditions

Breast CancerFatigue

Keywords

fatiguestage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization

    POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.

    24 weeks

Secondary Outcomes (2)

  • Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization

    24 weeks

  • Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization

    24 weeks

Study Arms (2)

Arm 1 - CoQ10 & Vitamin E

ACTIVE COMPARATOR

CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.

Dietary Supplement: CoQ10 & Vitamin EDietary Supplement: Placebo & Vitamin E

Arm 2 - Placebo & Vitamin E

PLACEBO COMPARATOR

Placebo-Vitamin E 100 mg/day in 3 doses

Dietary Supplement: Placebo & Vitamin E

Interventions

CoQ10 & Vitamin EDIETARY_SUPPLEMENT
Also known as: CoenzymeQ10
Arm 1 - CoQ10 & Vitamin E
Placebo & Vitamin EDIETARY_SUPPLEMENT
Arm 1 - CoQ10 & Vitamin EArm 2 - Placebo & Vitamin E

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19713, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MBCCOP - JHS Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65804, United States

Location

CCOP - Heartland Research Consortium

St Louis, Missouri, 63131, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, 27216, United States

Location

Southeastern Medical Oncology Center - Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

Caldwell Memorial Hospital

Lenoir, North Carolina, 28645, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1030, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

South Carolina Cancer Specialists, PA at Hilton Head Medical Center

Hilton Head Island, South Carolina, 29925, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, 24115-4788, United States

Location

Related Publications (2)

  • Vitolins MZ, Case LD, Rapp SR, Lively MO, Shaw EG, Naughton MJ, Giguere J, Lesser GJ. Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol. Patient Prefer Adherence. 2018 Apr 24;12:637-646. doi: 10.2147/PPA.S158682. eCollection 2018.

    PMID: 29731611BACKGROUND

  • Lesser GJ, Case D, Stark N, Williford S, Giguere J, Garino LA, Naughton MJ, Vitolins MZ, Lively MO, Shaw EG; Wake Forest University Community Clinical Oncology Program Research Base. A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol. 2013 Mar;11(1):31-42. doi: 10.1016/j.suponc.2012.03.003.

    PMID: 22682875RESULT

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

coenzyme Q10Vitamin E

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Glenn Lesser
Organization
Wake Forest University Comprehensive Cancer Center
glesser@wakehealth.edu
(336) 713-5440

Study Officials

  • Glenn J. Lesser, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

August 27, 2004

Primary Completion

August 31, 2009

Study Completion

August 31, 2009

Last Updated

September 29, 2021

Results First Posted

December 29, 2014

Record last verified: 2021-09

Locations

US(31)