A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Caner Patients
N/A
N/A
Female
Breast Cancer, Fatigue
Trial Information
A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Caner Patients
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of primary breast cancer
- Planned adjuvant chemotherapy
- No neoadjuvant chemotherapy
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- Any age
Sex
- Female
Menopausal status
- Not specified
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin at least 11 g/dL (supportive measures [i.e., epoetin alfa, transfusion, or
iron therapy] allowed)
Hepatic
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT and SGPT less than 2.5 times ULN
Renal
- Not specified
Cardiovascular
- No uncontrolled hypertension or hypertension requiring medication
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Cholesterol at least 160 mg/dL
- No recent involuntary weight loss (more than 5% of body weight within the past 3
months)
- No diabetes
- No uncontrolled thyroid dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Hematopoietic
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent corticosteroids for fatigue
- Concurrent corticosteroids for pre-chemotherapy antiemetic prophylaxis allowed
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent amphetamines (e.g., methylphenidate or modafinil) or other stimulants
for fatigue
- No concurrent anticoagulant therapy except to maintain catheter patency
- No concurrent statin therapy, including, but not limited to, any of the following
medications:
- Atorvastatin
- Cerivastatin
- Fluvastatin
- Mevastatin
- Pravastatin
- Rosuvastatin
- Simvastatin
- No other concurrent supplements containing vitamin E or coenzyme Q_10
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Effects of coenzyme Q10 by POMS-F at baseline, 8 weeks, 16 weeks, and 24 weeks
Principal Investigator
Glenn J. Lesser, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000331829
NCT ID:
NCT00096356
Start Date:
August 2004
Completion Date:
Related Keywords:
- Breast Cancer
- Fatigue
- 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
- Breast Neoplasms
- Fatigue
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
| Cancer Centers of the Carolinas - Eastside | Greenville, South Carolina 29601 |
| High Point Regional Hospital | High Point, North Carolina 27261 |
| Alamance Cancer Center at Alamance Regional Medical Center | Burlington, North Carolina 27216 |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
| MBCCOP - JHS Hospital of Cook County | Chicago, Illinois 60612 |
| Caldwell Memorial Hospital | Lenoir, North Carolina 28645 |
| Southeastern Medical Oncology Center - Goldsboro | Goldsboro, North Carolina 27534 |
| Helen F. Graham Cancer Center at Christiana Hospital | Newark, Delaware 19718 |
| CCOP - Heartland Research Consortium | St. Louis, Missouri 63131 |
| South Carolina Cancer Specialists, PA at Hilton Head Medical Center | Hilton Head Island, South Carolina 29925 |
