Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test L-Carnitine.

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".

The registry classes the interventions as drug.

Who Took Part

36 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: patients with evidence of metastatic breast cancer; patients having received previous anthracycline therapy or contraindication to anthracycline; patients having a contraindication to l-carnitine therapy.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2006-03 with completion listed for 2010-10.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main 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 (time frame: 1 year).

It also tracked 7 secondary outcomes, for example "Anthracycline-induced cardiotoxicity" and clinical cardiac outcomes, Serum L-carnitine levels, To assess: the safety of L-carnitine, the effect of anthracyclines on plasma L-carnitine levels and the correlation of L-carnitine levels with serum TnT and BNP levels.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of L-Carnitine in 36 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.