The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy in Colorectal Cancer Patients. Randomized Trial

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Dietary Supplement: Glutamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen. | Dietary Supplement: Glutamine<br> <br> * Other names: Resource Glutamine 3x10 gr per day;|
| No Intervention: Observation<br>The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis.. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography parameters | Electromyography action potential values will be compared between two patient groups. | 4 months interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological signs and symptoms |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glutamine, oxaliplatin, peripheral neuropathy