Clinical trial · Interventional
Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer.
Glutamine for the Prophylaxis of Vincristine-induced Neuropathy in Children and Adolescents With Cancer. A Single Center Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine (Pharmacological doses) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention arm
- 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)
- interventionNames
- Drug: Glutamine (Pharmacological doses)
- type
- NO_INTERVENTION
- label
- Standard of care arm
- description
- the usual standard of care
Primary outcomes (2)
- measure
- safety outcome
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available