Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Fatigue |
Dietary Supplement: coenzyme Q10 Dietary Supplement: vitamin E |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Caner Patients |
- Effects of coenzyme Q10 by POMS-F at baseline, 8 weeks, 16 weeks, and 24 weeks
- Effects of coenzyme Q10 on quality of life as measured by FACT-B with FACIT-F subscale, patient self-rating of fatigue, CES-D short-form, MOS social support; baseline, 8 weeks, 16 weeks, and 24 weeks
- Effects of coenzyme Q10 on depression as measured by FACT-B with FACIT-F subscale, patient self-rating of fatigue, CES-D short-form, MOS social support; baseline, 8 weeks, 16 weeks, and 24 weeks
| Estimated Enrollment: | 236 |
| Study Start Date: | August 2004 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 31 Study Locations| Principal Investigator: | Glenn J. Lesser, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00096356 History of Changes |
| Other Study ID Numbers: | CDR0000331829, CCCWFU-97202, WFU 97202 |
| Study First Received: | November 9, 2004 |
| Last Updated: | July 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Fatigue Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms Coenzyme Q10 Ubiquinone |
Vitamin E Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on June 17, 2013