Clinical trial · Interventional
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors
A Pilot Study Investigating the Effects of Glutamine and Vincristine-Induced Neuropathy in Pediatric Patients With Cancer
- 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)
RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine. PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neurotoxicity | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Glutamine
- description
- Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
- interventionNames
- Drug: Glutamine
- type
- PLACEBO_COMPARATOR
- label
- Arm II: Placebo
- description
- Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Incidence of Vincristine-induced Peripheral Neuropathy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients between the age of 5 and 21 years old. * Patients who demonstrate the ability to complete the assessment instruments at baseline. * Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of \> or = to 6mg/m2 of vincristine, or \> 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period. Exclusion Criteria: * Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis. * Patients with recurrent disease. * Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam. * Patients who have already received \> 8mg/m2 of vincristine, or \> 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent. * Patients with hepatic encephalopathy or hyperammonemia. * Patients with a focally abnormal neurologic exam.
References
Publications (0)
Data not yet available