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

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ClinicalTrials.gov Identifier: NCT00247975
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):

October 31, 2005
November 2, 2005
February 7, 2012
March 2006
October 2010   (Final data collection date for primary outcome measure)
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 ]
1) Change in EF (measure by RNA) at one year, compared to the patient’s own baseline.
Complete list of historical versions of study NCT00247975 on ClinicalTrials.gov Archive Site
  • 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 ]
  • "Anthracycline-induced cardiotoxicity" and clinical cardiac outcomes [ Time Frame: 1 year ]
  • Serum L-carnitine levels [ Time Frame: 4 months ]
  • To assess: the safety of L-carnitine [ Time Frame: 1 year ]
  • 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 ]
  • the effect of anthracyclines on plasma L-carnitine levels [ Time Frame: 4 months ]
  • the correlation of L-carnitine levels with serum TnT and BNP levels [ Time Frame: 4 months ]
  • A) Effect of L-carnitine versus placebo on:
  • 1) LV end-systolic and end-diastolic volumes (RNA)
  • 2) LV diastolic dysfunction (ECHO)
  • 3) serum TnT and BNP measured with each cycle of chemotherapy (immediately prior to and 3 days after chemotherapy)
  • 4) composite outcome of: cardiac death, clinical congestive heart failure, reduction in EF requiring termination of anthracycline therapy (LVEF reduction ≥ 10% and LVEF < 50%), dexrazoxane use or “anthracycline-induced cardiotoxicity”.
  • 5) adverse events (e.g. chemotherapy efficacy, seizures, nausea, diarrhea).
  • B)
  • 6) correlation of serum biomarkers (serum L-Carnitine levels, serum TnT, BNP) with surrogate markers of cardiotoxicity (LV ejection fraction, LV volumes and diastolic dysfunction) will be performed.
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Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy
Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer (PPACC)-Pilot Study

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.

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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Heart Failure
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2011
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CIHR #: 126541
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Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
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
Ottawa Heart Institute Research Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP