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

Primary Purpose

Breast Cancer, Fatigue

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CoQ10 & Vitamin E
Placebo & Vitamin E
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • CCOP - Santa Rosa Memorial Hospital
  • CCOP - Christiana Care Health Services
  • Helen F. Graham Cancer Center at Christiana Hospital
  • MBCCOP - Howard University Cancer Center
  • CCOP - Mount Sinai Medical Center
  • MBCCOP - JHS Hospital of Cook County
  • CCOP - Central Illinois
  • CCOP - Northern Indiana CR Consortium
  • CCOP - Cedar Rapids Oncology Project
  • MBCCOP - LSU Health Sciences Center
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Beaumont
  • CCOP - Metro-Minnesota
  • CCOP - Heartland Research Consortium
  • Missouri Baptist Cancer Center
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Cancer Research for the Ozarks
  • Alamance Cancer Center at Alamance Regional Medical Center
  • Southeastern Medical Oncology Center - Goldsboro
  • Pardee Memorial Hospital
  • High Point Regional Hospital
  • Caldwell Memorial Hospital
  • CCOP - Southeast Cancer Control Consortium
  • Wake Forest University Comprehensive Cancer Center
  • CCOP - Columbus
  • Cancer Centers of the Carolinas - Eastside
  • South Carolina Cancer Specialists, PA at Hilton Head Medical Center
  • CCOP - Upstate Carolina
  • Danville Regional Medical Center
  • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1 - CoQ10 & Vitamin E

Arm 2 - Placebo & Vitamin E

Arm Description

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

Placebo-Vitamin E 100 mg/day in 3 doses

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2004
Last Updated
September 28, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00096356
Brief Title
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Acronym
CoQ10
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 27, 2004 (Actual)
Primary Completion Date
August 31, 2009 (Actual)
Study Completion Date
August 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - CoQ10 & Vitamin E
Arm Type
Active Comparator
Arm Description
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
Arm Title
Arm 2 - Placebo & Vitamin E
Arm Type
Placebo Comparator
Arm Description
Placebo-Vitamin E 100 mg/day in 3 doses
Intervention Type
Dietary Supplement
Intervention Name(s)
CoQ10 & Vitamin E
Other Intervention Name(s)
CoenzymeQ10
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo & Vitamin E
Primary Outcome Measure Information:
Title
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
Description
POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
Description
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.
Time Frame
24 weeks
Title
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn J. Lesser, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Helen F. Graham Cancer Center at Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
MBCCOP - Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
MBCCOP - JHS Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Heartland Research Consortium
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Alamance Cancer Center at Alamance Regional Medical Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27216
Country
United States
Facility Name
Southeastern Medical Oncology Center - Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
High Point Regional Hospital
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27261
Country
United States
Facility Name
Caldwell Memorial Hospital
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1030
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Cancer Centers of the Carolinas - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
South Carolina Cancer Specialists, PA at Hilton Head Medical Center
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29925
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
City
Martinsville
State/Province
Virginia
ZIP/Postal Code
24115-4788
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29731611
Citation
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.
Results Reference
background
PubMed Identifier
22682875
Citation
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.
Results Reference
result

Learn more about this trial

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

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