NCT02024191

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ankara Education and Research Hospital · Other Government
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Our study population includes the colorectal cancer patient who is going to have mFOLFOX6 (modified, Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil l 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) regimen. We randomly assigned the patients into two groups. We administered glutamine at dose of 3x10 gr/day to one patient group concomitantly with mFOLFOX6 regimen and other group had no additional intervention. We performed questionnaire, neurological examination and EMG (Electromyography) before and after 4th cycle of mFOLFOX6 regimen in both patient groups. We planned to compare the neurological signs, symptoms and EMG action potentials between mFOLFOX6+Glutamine and only mFOLFOX6 group. We aimed to search the role of glutamine as a prophylactic agent against oxaliplatin induced neuropathy.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glutamine

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-01-01
• Completion: 2015-06-01
• First posted: 2013-12-31
• Last updated: 2013-12-31

Locations

1 site across 1 country: Turkey (Türkiye)