Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy

Summary

Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of breast cancer often requires the use of chemotherapy including "anthracyclines". Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians and researchers are continually seeking methods that will reduce the toxic effects of anthracycline treatment.

L-carnitine is a substance that is produced naturally in the body and is required for normal heart function. Animal studies have suggested that L-carnitine protects the heart from the effects of anthracyclines, however this has not been verified in humans.

This study will assess the potential role of L-carnitine in the prevention of anthracycline induced heart damage. The investigators will enroll 144 patients into this study. Patients will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine prior to and after their anthracycline therapy. Patients will undergo regular follow up and testing to assess heart function. The investigators believe that patients treated with L-carnitine will benefit and have fewer complications associated with anthracycline treatment.

Conditions

• Heart Failure

Interventions

DRUG

L-carnitine

Patients will be randomized to L-carnitine therapy or placebo. Patients in the treatment group will receive oral L-carnitine (3 grams daily) for 3 days prior to chemotherapy, 1 gram of intravenous L-carnitine (5 cc over 5 minutes, prior to chemotherapy) on the day of chemotherapy and oral L-carnitine (3 grams daily) for 3 days after chemotherapy.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Ottawa Heart Institute Research Corporation

  lead OTHER

Principal Investigators

• Benjamin JW Chow, MD, FRCPC · Ottawa Heart Institute Research Corporation

• Rob S Beanlands, MD, FRCPC · Ottawa Heart Institute Research Corporation

• Haissam Haddad, MD, FRCPC · Ottawa Heart Institute Research Corporation

• George Wells, M.Sc., PhD · Ottawa Heart Institute Research Corporation

• Susan Dent, MD, FRCPC · Ottawa Regional Cancer Centre

• Sean Hopkins, B.Sc, RPEBC · Ottawa Regional Cancer Centre

• Michele A Turek, MD, FRCPC · Ottawa Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Primary Completion

2010-10-31

Completion

2011-10-31

Countries

• Canada

Study Locations