Preventive Effect of Acetyl-L-carnitine on Oxaliplatin-induced Peripheral Neuropathy

What Was Tested

The trial (phase 2) is built around L-Carnitine.

With the prolongation of the overall survival time of patients with malignant tumors, the influence of oxaliplatin on the quality of life of patients with malignant tumors has gradually become prominent.

Large-scale clinical studies have approved it as a treatment for diabetic peripheral neuropathy.

It had two arms (groups): Acetyl-L-carnitine group(ALC group) (experimental) and Blank Control group (no intervention).

The registry classes the interventions as drug.

More on the Plan

Background 1.1 Epidemiological overview of oxaliplatin-induced peripheral neuropathy Gastrointestinal cancer is the most common malignant tumor in the world, mainly including Gastric cancer (GC), Colorectal cancer (CRC) and so on.

Oxaliplatin (OXA) is the third generation of platinum-based chemotherapy drugs, which is characterized by high efficiency, low toxicity and broad spectrum, and has become the main drug in the treatment of a variety of gastrointestinal malignant tumors.

However, with the widespread application of oxaliplatin, its related adverse reactions have gradually become prominent.

Acute OIPN mainly manifests as paresthesia, such as tingling and numbness induced or aggravated by cold stimulation, which usually appears several hours after administration and disappears within a few days.

Who Took Part

100 planned participants were the target.

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: Age ≥18 years old. The Eastern Cooperative Oncology Group (ECOG) performance status was 0 or 1. The predicted survival time was ≥12 months. Subjects will receive oxaliplatin-containing regimens, including. Laboratory values within 7 days before enrollment should meet the following criteria:.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: participating in other interventional clinical studies (unless participating in an observational study or in the follow-up phase of an interventional study);; hyponatremia, hypokalemia, hyperchloremic acidosis, adrenal failure and adrenocortical insufficiency (addison's disease), hepatic coma, diabetes mellitus, brain or leptomeningeal metastases;; history of alcohol dependence or concomitant use of other drugs known to affect serotonin levels;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

It started in 2022-11-01 with completion listed for 2024-12-31.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Incidence rate of OIPN (time frame: week 24 after enrollment).

It also tracked 3 secondary outcomes, for example Severity of OIPN, Time of occurrence and The prognosis of tumor.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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