L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients

What Was Tested

The trial (phase 1, phase 2) is built around Carnosine.

This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .

It had two arms (groups): Treatment group (experimental) and Control group (no intervention).

This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only.

The registry classes the interventions as drug.

More on the Plan

Blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples.

Who Took Part

Enrollment: 65 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Elderly males and females with age (˃18 and ˂60).

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: suffering from diabetes mellitus; suffering from peripheral neuropathy as a result of any other disease or drug; suffering from epilepsy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Carnosine group and the comparison group ran side by side rather than switching.

Being open-label, the Carnosine study did not mask who received what.

It started in 2015-06 with completion listed for 2016-11.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits (time frame: Three months).

It also tracked 1 secondary outcome, for example Assessment of tumor markers (CA,CEA) in blood.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Carnosine in 65 people.

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

More context: the Carnosine compound page, all human trials.