Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.
NCT ID: NCT07287592
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2025-12-30
2027-04-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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 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)
* Standard of care arm: Thirty five patients will be assigned as a control group with no medication given
PREVENTION
NONE
Study Groups
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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)
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
Standard of care arm
the usual standard of care
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Ain Shams University
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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nihal hussien aly mostafa, assistant professsor of pediat
Role: CONTACT
Phone: +201001053961
Email: [email protected]
Facility Contacts
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nihal hussien aly mostafa, MD of pediatrics
Role: primary
fatma soliman ebeid, MD of pediatrics
Role: backup
Other Identifiers
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FMASU R 146/2021
Identifier Type: -
Identifier Source: org_study_id