Clinical trial NCT00096356: Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-11-09
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
timeFrame: 24 weeks
Secondary outcomes:
measure: Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
timeFrame: 24 weeks
measure: Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Santa Rosa
country: United States
facility: CCOP - Santa Rosa Memorial Hospital
state: California
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Newark
country: United States
facility: Helen F. Graham Cancer Center at Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: MBCCOP - Howard University Cancer Center
state: District of Columbia
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Chicago
country: United States
facility: MBCCOP - JHS Hospital of Cook County
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Saint Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: CCOP - Heartland Research Consortium
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: CCOP - St. Louis-Cape Girardeau
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Burlington
country: United States
facility: Alamance Cancer Center at Alamance Regional Medical Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center - Goldsboro
state: North Carolina
city: Hendersonville
country: United States
facility: Pardee Memorial Hospital
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Hospital
state: North Carolina
city: Lenoir
country: United States
facility: Caldwell Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas - Eastside
state: South Carolina
city: Hilton Head Island
country: United States
facility: South Carolina Cancer Specialists, PA at Hilton Head Medical Center
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Danville
country: United States
facility: Danville Regional Medical Center
state: Virginia
city: Martinsville
country: United States
facility: Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: Glenn J. Lesser, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.