Trials Sponsors Conditions Drugs Pricing

Conditions

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

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
Wake Forest University Health Sciences
Otherlead

Study Sites (31)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19713, United States

MBCCOP - Howard University Cancer Center

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

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

MBCCOP - JHS Hospital of Cook County

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)

BenzopyransPyrans

Results Point of Contact

Title: Dr. Glenn Lesser
Organization: Wake Forest University Comprehensive Cancer Center

Study Officials

Glenn J. Lesser, MD
Wake Forest University Health Sciences
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

236 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Arm 1 - CoQ10 & Vitamin E

Arm 2 - Placebo & Vitamin E

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Arm 1 - CoQ10 & Vitamin E

Arm 2 - Placebo & Vitamin E

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations