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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamine | Experimental | The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen. |
|
| Observation | No Intervention | The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis.. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Electromyography parameters | Electromyography action potential values will be compared between two patient groups. | 4 months interval |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological signs and symptoms | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozan Yazici, MD | Contact | +90 312 5084610 | drozanyazici@gmail.com | |
| Nuriye Ozdemir, MD | Contact | +90 312 5084601 | nyozdemir@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Numune Education and Research Hospital | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| D021542 | Amino Acids, Neutral |