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Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.

NCT07287592 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-17

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and those who did not.

Participants will:

receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for 14 consecutive days from d 1 of induction and 14 days from d1 of continuation .

• Subjects will be asked to return for a complete study assessments visit every 14-days during supplementation period for a total of 4 visits Keep a diary of their symptoms of neuropathy and compliance to treatment and any adverse event

Conditions

Interventions

DRUG

Glutamine (Pharmacological doses)

glutamine is an essential amino acid. It will be provided in a powder form. It will be dissolved in at least 8 ounces of hot or cold liquid. It can also be mixed with a soft food such as pudding

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2026-12-30
Completion
2027-04-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287592 on ClinicalTrials.gov