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

Ankara Education and Research Hospital

Status and phase: Unknown; Phase 3

Conditions: Peripheral Neuropathy

Treatments: Dietary Supplement: Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02024191

031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Glutamine

Experimental group

Description:

The patient group had 3x10 gr daily glutamine during first 4 cycles of mFOLFOX6 regimen.

Treatment:

Dietary Supplement: Glutamine

Observation

No Intervention group

Description:

The group who had only mFOLFOX6 regimen, no additional intervention for neuropathy prophylaxis..