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



Status:Completed
Conditions:Breast Cancer, Cancer, Other Indications
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:August 2004
End Date:August 2009

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A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients

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.

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:

- 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
We found this trial at
31
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2270
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Martinsville, VA
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4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
2732
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Miami Beach, FL
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
2274
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Winston-Salem, NC
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
1898
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Ann Arbor, MI
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2312
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Burlington, NC
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Cedar Rapids, Iowa 52403
1544
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Cedar Rapids, IA
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Chicago, Illinois 60612
1730
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Chicago, IL
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
2008
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Columbus, OH
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142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
2293
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Danville, VA
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Decatur, Illinois 62526
1734
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Decatur, IL
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Goldsboro, North Carolina 27534
2410
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Goldsboro, NC
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Greenville, South Carolina 29615
2227
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Greenville, SC
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800 N Justice St
Hendersonville, North Carolina 28791
(828) 696-1000
Pardee Memorial Hospital Pardee Hospital is a not-for-profit community hospital founded in 1953 and is...
2200
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Hendersonville, NC
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High Point, North Carolina 27261
2286
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High Point, NC
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?
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Hilton Head Island, SC
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Lenoir, North Carolina 28645
2221
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Lenoir, NC
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
(504) 568-3435
MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
2099
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New Orleans, LA
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
2357
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Newark, DE
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Newark, DE
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Phoenix, Arizona 85006
1116
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Phoenix, AZ
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Royal Oak, Michigan 48073
1922
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Royal Oak, MI
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Saint Louis, Missouri 63141
1708
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Saint Louis, MO
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3015 N Ballas Rd
Saint Louis, Missouri 63131
(314) 996-5151
Missouri Baptist Cancer Center The Cancer Center at Missouri Baptist is a member of Heartland...
1710
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Saint Louis, MO
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Saint Louis, Missouri 63131
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Saint Louis, MO
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Saint Louis Park, Minnesota 55416
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Saint Louis Park, MN
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Santa Rosa, California 95403
633
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Santa Rosa, CA
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South Bend, Indiana 46601
1803
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South Bend, IN
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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1730 E Republic Rd
Springfield, Missouri 65804
(417) 269-4520
CCOP - Cancer Research for the Ozarks Cancer Research for the Ozarks (CRO), also known...
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Springfield, MO
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Washington, District of Columbia 20060
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Washington,
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Winston-Salem, North Carolina 27104
2271
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Winston-Salem, NC
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