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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 Caner Patients


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer, Fatigue

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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 CarolinaSpartanburg, South Carolina  29303
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Danville Regional Medical CenterDanville, Virginia  24541
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Pardee Memorial HospitalHendersonville, North Carolina  28791
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
High Point Regional HospitalHigh Point, North Carolina  27261
Alamance Cancer Center at Alamance Regional Medical CenterBurlington, North Carolina  27216
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
MBCCOP - JHS Hospital of Cook CountyChicago, Illinois  60612
Caldwell Memorial HospitalLenoir, North Carolina  28645
Southeastern Medical Oncology Center - GoldsboroGoldsboro, North Carolina  27534
Helen F. Graham Cancer Center at Christiana HospitalNewark, Delaware  19718
CCOP - Heartland Research ConsortiumSt. Louis, Missouri  63131
South Carolina Cancer Specialists, PA at Hilton Head Medical CenterHilton Head Island, South Carolina  29925