The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

Peripheral Neuropathy Clinical Trial

— GELUPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024191
• Other study ID #: 031
• Status: Recruiting
• Phase: Phase 3
• First received: December 25, 2013
• Last updated: December 30, 2013
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2013
• Source: Ankara Education and Research Hospital
• Contact: Ozan Yazici, MD
• Phone: +90 312 5084610
• Email: drozanyazici[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Dietary Supplement:
• Glutamine

Locations

Country	Name	City	State
Turkey	Ankara Numune Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromyography parameters	Electromyography action potential values will be compared between two patient groups.	4 months interval	No
Secondary	Neurological signs and symptoms		4 months	No