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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247975
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : February 7, 2012
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: L-carnitine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer (PPACC)-Pilot Study
Study Start Date : March 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. To compare the effects of L-carnitine therapy versus placebo on left ventricular (LV) ejection fraction (EF) as a marker of anthracycline induced cardiotoxicity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To compare the effects of L-carnitine therapy versus placebo on: other potential markers of anthracycline induced cardiotoxicity such as LV volume, LV systolic and diastolic function, troponin T (TnT) and NT-pro-brain natriuretic peptide (BNP) [ Time Frame: 1 year ]
  2. "Anthracycline-induced cardiotoxicity" and clinical cardiac outcomes [ Time Frame: 1 year ]
  3. Serum L-carnitine levels [ Time Frame: 4 months ]
  4. To assess: the safety of L-carnitine [ Time Frame: 1 year ]
  5. the predictive value of serum biomarkers (TnT, BNP, and L-carnitine levels) for cardiotoxicity and cardiac outcome (ejection fraction, LV volumes, congestive heart failure, and cardiac death) [ Time Frame: 1 year ]
  6. the effect of anthracyclines on plasma L-carnitine levels [ Time Frame: 4 months ]
  7. the correlation of L-carnitine levels with serum TnT and BNP levels [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients must have histologically or cytologically indicated breast cancer (stages I, II, III) eligible for adjuvant anthracycline chemotherapy [FEC100 or AC-Taxol(paclitaxel) every 21 days.
  • HER2 negative or HER2 positive breast cancer by immunohistochemistry (IHC3+) and/or fluorescent in-situ hybridization.
  • Eastern cooperative oncology group (ECOG) performance status = 0, 1, 2
  • Age ≥ 18 years old.
  • Ability to understand and the willingness to sign a written informed consent document.
  • The effects of L-carnitine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  • Patients with evidence of metastatic breast cancer.
  • Resting LV ejection fraction < 50%.
  • Patients having received previous anthracycline therapy or contraindication to anthracycline.
  • Patients having a contraindication to L-carnitine therapy
  • Dexrazoxane therapy at the time of enrollment.
  • Patients with abnormal baseline bloodwork:

    • hemoglobin ≤ 100 mg/L
    • platelets ≤ 100 x 10^9/L
    • white blood cells ≤ 4 x 10^9/L
    • creatinine, AST, ALT, bilirubin > 1.5 x the upper normal limits
  • Participation in another randomized clinical trial.
  • Patients having significant cardiac disease (previous myocardial infarction, congestive heart failure, or hemodynamically significant valvular heart disease) that would limit compliance with study requirements.
  • Patients taking medication that may affect LV function (b-blockers, amiodarone, ACE-inhibitors, calcium channel blockers, or digoxin).
  • Patients with symptoms of heart failure.
  • Patients unable to participate in a study requiring long term follow up.
  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247975

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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Benjamin JW Chow, MD, FRCPC Ottawa Heart Institute Research Corporation
Study Chair: Rob S Beanlands, MD, FRCPC Ottawa Heart Institute Research Corporation
Study Chair: Haissam Haddad, MD, FRCPC Ottawa Heart Institute Research Corporation
Study Chair: George Wells, M.Sc., PhD Ottawa Heart Institute Research Corporation
Study Chair: Susan Dent, MD, FRCPC Ottawa Regional Cancer Centre
Study Chair: Sean Hopkins, B.Sc, RPEBC Ottawa Regional Cancer Centre
Study Chair: Michele A Turek, MD, FRCPC Ottawa Hospital
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Responsible Party: Ottawa Heart Institute Research Corporation Identifier: NCT00247975    
Other Study ID Numbers: CIHR #: 126541
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012
Keywords provided by Ottawa Heart Institute Research Corporation:
Breast cancer
Anthracycline Cardiotoxicity
Primary prevention
Anthracycline induced cardiotoxicity
Left Ventricular Ejection Fraction
Additional relevant MeSH terms:
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Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries