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The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy (GELUPO)

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ClinicalTrials.gov Identifier: NCT02024191
Recruitment Status : Unknown
Verified December 2013 by Ozan Yazici, Ankara Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Ozan Yazici, 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.

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Dietary Supplement: Glutamine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy in Colorectal Cancer Patients. Randomized Trial
Study Start Date : December 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glutamine
The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen.
Dietary Supplement: Glutamine
Other Name: Resource Glutamine 3x10 gr per day

No Intervention: Observation
The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis..



Primary Outcome Measures :
  1. Electromyography parameters [ Time Frame: 4 months interval ]
    Electromyography action potential values will be compared between two patient groups.


Secondary Outcome Measures :
  1. Neurological signs and symptoms [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024191


Contacts
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Contact: Ozan Yazici, MD +90 312 5084610 drozanyazici@gmail.com
Contact: Nuriye Ozdemir, MD +90 312 5084601 nyozdemir@yahoo.com

Locations
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Turkey
Ankara Numune Education and Research Hospital Recruiting
Ankara, Turkey, 06230
Contact: Ozan Yazici, MD    +90 312 5084610    drozanyazici@gmail.com   
Contact: Nuriye Ozdemir, MD    +90 312 5084601    nyozdemir@yahoo.com   
Principal Investigator: Ozan Yazici, MD         
Sponsors and Collaborators
Ankara Education and Research Hospital
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Responsible Party: Ozan Yazici, MD, Ankara Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02024191    
Other Study ID Numbers: 031
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013
Keywords provided by Ozan Yazici, Ankara Education and Research Hospital:
glutamine
oxaliplatin
peripheral neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases