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Sponsors and Collaborators: |
University of Ottawa Heart Institute Canadian Institutes of Health Research (CIHR) |
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Information provided by: | University of Ottawa Heart Institute |
ClinicalTrials.gov Identifier: | NCT00247975 |
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 | Intervention | Phase |
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Heart Failure |
Drug: L-carnitine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Primary Prevention of Anthracycline-Induced Cardiotoxicity With L-Carnitine in Patients With Breast Cancer (PPACC)-Pilot Study |
Estimated Enrollment: | 144 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | October 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with abnormal baseline bloodwork:
Contact: Benjamin JW Chow, MD, FRCPC | (613) 761-4044 | bchow@ottawaheart.ca |
Canada, Ontario | |
University of Ottawa Heart Institute | Recruiting |
Ottawa, Ontario, Canada, K1Y 4W7 | |
Contact: Benjamin JW Chow, MD, FRCPC (613) 761-4044 bchow@ottawaheart.ca |
Principal Investigator: | Benjamin JW Chow, MD, FRCPC | University of Ottawa Heart Institute |
Study Chair: | Rob S Beanlands, MD, FRCPC | University of Ottawa Heart Institute |
Study Chair: | Haissam Haddad, MD, FRCPC | University of Ottawa Heart Institute |
Study Chair: | George Wells, M.Sc., PhD | University of Ottawa Heart Institute |
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 |
Responsible Party: | University of Ottawa Heart Institute ( Dr Benjamin Chow BSc MD FRCPC FACC ) |
Study ID Numbers: | CIHR #: 126541 |
Study First Received: | October 31, 2005 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00247975 |
Health Authority: | Canada: Health Canada |
L-carnitine Breast cancer Anthracycline Cardiotoxicity Primary prevention |
Anthracycline induced cardiotoxicity Breast Cancer Left Ventricular Ejection Fraction |
Heart Failure Heart Diseases Skin Diseases |
Breast Neoplasms Carnitine Breast Diseases |
Neoplasms Vitamin B Complex Neoplasms by Site Growth Substances Vitamins |
Physiological Effects of Drugs Cardiovascular Diseases Micronutrients Pharmacologic Actions |