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

Ain Shams University

Status and phase: Not yet enrolling; Phase 3

Conditions: Cancer; Neuropathy

Treatments: Drug: Glutamine (Pharmacological doses)

Study type: Interventional

Funder types: Other

Identifiers

NCT07287592

FMASU R 146/2021

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Intervention arm

Active Comparator group

Description:

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)

Treatment:

Drug: Glutamine (Pharmacological doses)

Standard of care arm

No Intervention group

Description:

the usual standard of care