Breast Cancer Clinical Trial
— CoQ10Official title:
A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
Verified date | September 2021 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 236 |
Est. completion date | August 31, 2009 |
Est. primary completion date | August 31, 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Alamance Cancer Center at Alamance Regional Medical Center | Burlington | North Carolina |
United States | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | MBCCOP - JHS Hospital of Cook County | Chicago | Illinois |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | Southeastern Medical Oncology Center - Goldsboro | Goldsboro | North Carolina |
United States | Cancer Centers of the Carolinas - Eastside | Greenville | South Carolina |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | High Point Regional Hospital | High Point | North Carolina |
United States | South Carolina Cancer Specialists, PA at Hilton Head Medical Center | Hilton Head Island | South Carolina |
United States | Caldwell Memorial Hospital | Lenoir | North Carolina |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | Helen F. Graham Cancer Center at Christiana Hospital | Newark | Delaware |
United States | CCOP - Western Regional, Arizona | Phoenix | Arizona |
United States | CCOP - Beaumont | Royal Oak | Michigan |
United States | CCOP - Heartland Research Consortium | Saint Louis | Missouri |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota |
United States | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | MBCCOP - Howard University Cancer Center | Washington | District of Columbia |
United States | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
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 Q1 — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 24 weeks | |
Secondary | 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. | 24 weeks |
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