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
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
Eligibility
Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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
Primary outcome measure(s)
safety outcome — 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
primary objective outcome — 3 months the number of participants who develop neuropathy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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