Clinical trial · Interventional
The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy
The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy in Colorectal Cancer Patients. Randomized Trial
NCT02024191CI-TRIAL-00013265GELUPOunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we aimed to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Glutamine
- description
- The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen.
- interventionNames
- Dietary Supplement: Glutamine
- type
- NO_INTERVENTION
- label
- Observation
- description
- The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis..
Primary outcomes (1)
- measure
- Electromyography parameters
- timeFrame
- 4 months interval
- description
- Electromyography action potential values will be compared between two patient groups.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 20 - 65 years * Operated and non operated colorectal cancer patients * Patient administering mFOLFOX 6 ( Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) Exclusion Criteria: * Patients who had chemotherapy in last 6 months * Diabetes Mellitus * Sensorimotor polyneuropathy * Anemia
References
Publications (0)
Data not yet available
No reference posted for this study.