S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo

What Was Tested

The trial (phase 3) is built around L-Carnitine.

It had two arms (groups): Arm I (experimental) and Arm II (placebo comparator).

Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.

Patients receive oral placebo 3 times daily for 24 weeks.

The registry classes the interventions as dietary supplement and other.

More on the Plan

OUTLINE: This is a multicenter study.

Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks. * Arm II: Patients receive oral placebo 3 times daily for 24 weeks.

Patients complete the FACT-Taxane Trial Outcome Index and the FACIT-Fatigue Symptom Module questionnaires at baseline, at 12, 24, and 36 weeks, and at 1 and 2 years.

Blood samples are collected at baseline and at week 12 for biomarker analysis (nerve growth factor levels) by ELISA, DNA extraction, and genotyping analysis.

Who Took Part

437 actual participants took part.

It was open to women only aged from 18 years up to 120 years.

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

Examples of who could join: Histologically confirmed primary invasive adenocarcinoma of the breast. Stage I-III disease. No metastatic disease. Must have undergone modified radical mastectomy or breast-sparing surgery. No history of neuropathy.

The full record lists 33 inclusion and 0 exclusion criteria.

How the Study Was Run

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

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

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 and investigator.

It started in 2009-09 with completion listed for 2012-01.

It ran at 295 sites in United States (295).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: 12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups (time frame: 12 weeks post-registration).

It also tracked 2 secondary outcomes, for example 12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups and 12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 437 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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