Back to resultsThe Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy (GELUPO)
Primary Purpose
Peripheral Neuropathy
Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Glutamine
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Neuropathy focused on measuring glutamine, oxaliplatin, peripheral neuropathy
Eligibility 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
Sites / Locations
- Ankara Numune Education and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Glutamine
Observation
Arm Description
The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen.
The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis..
Outcomes
Primary Outcome Measures
Electromyography parameters
Electromyography action potential values will be compared between two patient groups.
Secondary Outcome Measures
Neurological signs and symptoms
Full Information
NCT ID
NCT02024191
First Posted
December 25, 2013
Last Updated
December 30, 2013
Sponsor
Ankara Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02024191
Brief Title
The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy
Acronym
GELUPO
Official Title
The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy in Colorectal Cancer Patients. Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Education and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
glutamine, oxaliplatin, peripheral neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glutamine
Arm Type
Experimental
Arm Description
The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis..
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Other Intervention Name(s)
Resource Glutamine 3x10 gr per day
Primary Outcome Measure Information:
Title
Electromyography parameters
Description
Electromyography action potential values will be compared between two patient groups.
Time Frame
4 months interval
Secondary Outcome Measure Information:
Title
Neurological signs and symptoms
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ozan Yazici, MD
Phone
+90 312 5084610
Email
drozanyazici@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nuriye Ozdemir, MD
Phone
+90 312 5084601
Email
nyozdemir@yahoo.com
Facility Information:
Facility Name
Ankara Numune Education and Research Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozan Yazici, MD
Phone
+90 312 5084610
Email
drozanyazici@gmail.com
First Name & Middle Initial & Last Name & Degree
Nuriye Ozdemir, MD
Phone
+90 312 5084601
Email
nyozdemir@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ozan Yazici, MD
12. IPD Sharing Statement
Learn more about this trial
The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy
We'll reach out to this number within 24 hrs