The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

Last updated: December 30, 2013
Sponsor: Ankara Education and Research Hospital
Overall Status: Trial Status Unknown

Phase

3

Condition

Neurologic Disorders

Peripheral Neuropathy

Treatment

N/A

Clinical Study ID

NCT02024191
031
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 1day, 5-fluorouracil 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours)

Exclusion

Exclusion Criteria:

  • Patients who had chemotherapy in last 6 months

  • Diabetes Mellitus

  • Sensorimotor polyneuropathy

  • Anemia

Study Design

Total Participants: 80
Study Start date:
December 01, 2013
Estimated Completion Date:
June 30, 2015

Study 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.

Connect with a study center

  • Ankara Numune Education and Research Hospital

    Ankara, 06230
    Turkey

    Active - Recruiting

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