- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247975
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
"Anthracycline-induced cardiotoxicity" and clinical cardiac outcomes
Time Frame: 1 year
|
1 year
|
Serum L-carnitine levels
Time Frame: 4 months
|
4 months
|
To assess: the safety of L-carnitine
Time Frame: 1 year
|
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
|
1 year
|
the effect of anthracyclines on plasma L-carnitine levels
Time Frame: 4 months
|
4 months
|
the correlation of L-carnitine levels with serum TnT and BNP levels
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIHR #: 126541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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