Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer (CoQ10)

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Fatigue

Treatments: Dietary Supplement: CoQ10 & Vitamin E; Dietary Supplement: Placebo & Vitamin E

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00096356

U10CA081851 (U.S. NIH Grant/Contract)

REBACCCWFU-97202

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 236 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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236 participants in 2 patient groups, including a placebo group

Arm 1 - CoQ10 & Vitamin E

Active Comparator group

Description:

CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.

Treatment:

Dietary Supplement: CoQ10 & Vitamin E

Dietary Supplement: Placebo & Vitamin E

Arm 2 - Placebo & Vitamin E

Placebo Comparator group

Description:

Placebo-Vitamin E 100 mg/day in 3 doses

Treatment:

Dietary Supplement: Placebo & Vitamin E