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NCT Number: NCT07287592

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

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

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Key information

Conditions

Neuropathy Cancer Neoplasms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11517, Egypt

Location contact

fatma soliman ebeid, MD of pediatrics

CONTACT

fatma soliman ebeid, MD of pediatrics

SUB_INVESTIGATOR

iman ahmed ragab, MD of pediatrics

SUB_INVESTIGATOR

marwa waheed tolba, md of pediatrics

SUB_INVESTIGATOR

nihal hussien aly mostafa, MD of pediatrics

CONTACT

[email protected]

0224175103

salwa mostafa abdel kader, md of pediatrics

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No sex predilection.
  • Age: 6 years to 18 years
  • 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
  • Patients with score less than 5 on pediatric modified total neuropathy scale at Time 0

Exclusion criteria

  • Patients with CNS tumors
  • 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

Treatment and study plan

Glutamine (Pharmacological doses)

Drug

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

Primary outcomes

  1. safety outcome

    Time frame: 12 months

    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

  2. primary objective outcome

    Time frame: 3 months

    the number of participants who develop neuropathy

Study contacts

Contact information is provided by the study sponsor or research team.

nihal hussien aly mostafa, assistant professsor of pediat

CONTACT

[email protected]

+201001053961

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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