Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-18
SponsorAin Shams University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Glutamine (Pharmacological doses)
Drugglutamine 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
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Intervention armActive comparator 1 intervention
Group B: Standard of care armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 months2
primary objective outcome
the number of participants who develop neuropathy
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: