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The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02024191
Acronym
GELUPO
Enrollment
80
Registered
2013-12-31
Start date
2013-12-31
Completion date
2015-06-30
Last updated
2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy

Keywords

glutamine, oxaliplatin, peripheral neuropathy

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.

Interventions

DIETARY_SUPPLEMENTGlutamine

Sponsors

Ankara Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Electromyography parameters4 months intervalElectromyography action potential values will be compared between two patient groups.

Secondary

MeasureTime frame
Neurological signs and symptoms4 months

Countries

Turkey (Türkiye)

Contacts

Primary ContactOzan Yazici, MD
drozanyazici@gmail.com+90 312 5084610
Backup ContactNuriye Ozdemir, MD
nyozdemir@yahoo.com+90 312 5084601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026