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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Cancer; Neuropathy
• Intervention / Treatment: Drug: Glutamine (Pharmacological doses)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: nihal hussien aly mostafa, assistant professsor of pediat; Phone Number: +201001053961; Email: nihal.hussien.ali@gmail.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11517
      • Ain Shams University
      • Contact: nihal hussien aly mostafa, MD of pediatrics; Phone Number: 0224175103; Email: NIHAL.HUSSIEN.ALI@GMAIL.COM
      • Contact: fatma soliman ebeid, MD of pediatrics
      • Sub-Investigator: fatma soliman ebeid, MD of pediatrics
      • Sub-Investigator: iman ahmed ragab, MD of pediatrics
      • Sub-Investigator: salwa mostafa abdel kader, md of pediatrics
      • Sub-Investigator: marwa waheed tolba, md of pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention arm; Thirty five patients will receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for forteen consecutive days starting from induction and forteen days starting from d1 of continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007)	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
No Intervention: Standard of care arm; the usual standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
primary objective outcome	the number of participants who develop neuropathy	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cancer; vincristine; neuropathy
• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Neutral; Glutamine
• Other Study ID Numbers: FMASU R 146/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No