The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

Phase 3

• Conditions: Peripheral Neuropathy
• Interventions: Dietary Supplement: Glutamine

• Registration Number: NCT02024191
• Lead Sponsor: Ankara Education and Research Hospital

Brief 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.

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-25
• Study First Submitted QC: 2013-12-30
• Last Update Submitted: 2013-12-30
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31
• Primary Completion: 2015-01
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine	Glutamine	The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen.

Primary Outcome Measures

Name	Time	Method
Electromyography parameters	4 months interval	Electromyography action potential values will be compared between two patient groups.

Secondary Outcome Measures

Name	Time	Method
Neurological signs and symptoms	4 months

Trial Locations

Locations (1)

Ankara Numune Education and Research Hospital; 🇹🇷 Ankara, Turkey