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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
- 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.
- 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 ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00247975
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|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|