Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)

What Was Tested

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

Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle.

It had two arms (groups): Arm 1 (experimental) and Arm 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Males or females aged \>/= 18 years. Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or clear cell tumors) or Adenocarcinoma of the prostate. Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy. Progression of disease (Ovarian Cancer) or symptomatic relapse after previous therapy (elevated CA125 levels alone are insufficient for inclusion) WHO performance status 0 to 1. No clinical residual neuropathy (CTCAE Grade 0 at baseline).

The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: symptomatic brain metastases requiring whole- brain irradiation; diabetes mellitus (even if controlled only by special diet); history of chronic hepatitis b or c, or known hiv infection.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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, investigator and outcomes assessor.

It started in 2008-08 with completion listed for 2010-02.

It ran at 22 sites in Germany (6), France (5), Italy (4), Netherlands (4), United Kingdom (2) and Belgium (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events (time frame: Start of Sagopilone treatment until at most 6 cycles + 1 month).

It also tracked 11 secondary outcomes, for example Safety of Sagopilone in combination with ALC.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 150 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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