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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096356
• Other study ID #: REBACCCWFU-97202
• Secondary ID: U10CA081851
• Status: Completed
• Phase: Phase 1
• Start date: August 27, 2004
• Est. completion date: August 31, 2009

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Dietary Supplement:
• CoQ10 & Vitamin E

• Placebo & Vitamin E

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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