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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

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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



- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with
breast cancer.


- 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

PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of primary breast cancer

- Planned adjuvant chemotherapy

- No neoadjuvant chemotherapy

- Hormone receptor status:

- Not specified



- Any age


- Female

Menopausal status

- Not specified

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified


- Hemoglobin at least 11 g/dL (supportive measures [i.e., epoetin alfa, transfusion, or
iron therapy] allowed)


- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT and SGPT less than 2.5 times ULN


- Not specified


- No uncontrolled hypertension or hypertension requiring medication


- 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

- No diabetes

- No uncontrolled thyroid dysfunction


Biologic therapy

- See Hematopoietic


- See Disease Characteristics

Endocrine therapy

- No concurrent corticosteroids for fatigue

- Concurrent corticosteroids for pre-chemotherapy antiemetic prophylaxis allowed


- Not specified


- Not specified


- 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

- Atorvastatin

- Cerivastatin

- Fluvastatin

- Mevastatin

- Pravastatin

- Rosuvastatin

- Simvastatin

- No other concurrent supplements containing vitamin E or coenzyme Q_10

Type of Study:


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


United States: Food and Drug Administration

Study ID:




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



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