Status:
TERMINATED
Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Heart Failure
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00247975
Start Date
March 1 2006
End Date
October 1 2011
Last Update
August 16 2022
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7