L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

What Was Tested

The trial (phase 4) is built around L-Carnitine.

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

Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

The registry classes the interventions as drug and other.

More on the Plan

Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Who Took Part

Enrollment: 2 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: Diagnosis of breast cancer. Scheduled to receive ≥ 1 of the following chemotherapy drugs:. Albumin-bound paclitaxel (Abraxane). Life expectancy ≥ 6 months. Not pregnant or nursing.

The full record lists 25 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

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

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and investigator.

It started in 2007-01-02 with completion listed for 2008-04-02.

It ran at 2 sites in United States (2).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork (time frame: baseline, days 1 and 2 post chemo x 4 cycles).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 2 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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