L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors

What Was Tested

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

It had two arms (groups): L-carnitine (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

It affects the quality of life (QoL) of patients and could also be a factor that affects compliance with treatment.

Who Took Part

Enrollment: 4 actual participants took part.

It was open to people of any sex 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: Histologically confirmed GIST patients who are taking imatinib. Age 18years or older. Patients experienced muscle cramps for more than 8 times (pain of NRS \> 4) or 4 times (pain of NRS \>7) within last 4 weeks. Life expectancy \> 6 months. ECOG performance status of 0-3.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: patients with renal disease receiving hemodialysis; liver cirrhosis patients with child-pugh class b or c; patients with history of hypersensitivity to drugs including l-carnitine or nutritional supplements.

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2018-03-01 with completion listed for 2019-12-24.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of patients who have occurrence of muscle cramps ( numeric rating scale score > 4) (time frame: 4 weeks).

It also tracked 5 secondary outcomes, for example Change in average numeric rating scale scores of muscle cramps, Rate of patients who have duration of muscle cramps (numeric rating scale score > 4), questionnaire(Quality of Life), plasma concentration level and recurrence rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 4 people.

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

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.