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

Phase 3Not Yet RecruitingNCT07287592

Ain Shams University70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Neuropathy Cancer

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. No sex predilection. 2. Age: 6 years to 18 years 3. Children and adolescents diagnosed with hematological malignancy or solid tumors expected to receive a cumulative dose of 6 mg/m2 of VCR over a 12 week period (or \>6 mg/m2 if individual VCR doses were capped at 2 mg) according to their primary cancer treatment protocol 4. Patients with score less than 5 on pediatric modified total neuropathy scale at Time 0 Exclusion Criteria: 1. Patients with CNS tumors 2. Patients with focal neurologic findings or CNS metastasis Patients with premorbid developmental disorders, neuromuscular disorders or diabetes mellitus Patients with recurrent disease already exposed to \>8 mg/m2 of VCR Patients with score more than 5 on pediatric modified total neuropathy scale

Outcomes

Primary Outcomes

safety outcome

The primary safety endpoint was the the number of participants who will report bleeding tendency episodes and number of participants with significant impairment of liver or kidney functions

Time frame: 12 months

primary objective outcome

the number of participants who develop neuropathy

Time frame: 3 months