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Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer (PPACC)-Pilot Study

Phase 2/Phase 3
18 Years
Not Enrolling
Heart Failure

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Trial Information

Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer (PPACC)-Pilot Study

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Benjamin JW Chow, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Ottawa Heart Institute


Canada: Health Canada

Study ID:

CIHR #: 126541



Start Date:

March 2006

Completion Date:

October 2011

Related Keywords:

  • Heart Failure
  • L-carnitine
  • Breast cancer
  • Anthracycline Cardiotoxicity
  • Primary prevention
  • Anthracycline induced cardiotoxicity
  • Breast Cancer
  • Left Ventricular Ejection Fraction
  • Breast Neoplasms
  • Heart Failure