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The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy

NCT ID: NCT02024191

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Peripheral Neuropathy

Keywords

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glutamine oxaliplatin peripheral neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Glutamine

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

Group Type EXPERIMENTAL

Glutamine

Intervention Type DIETARY_SUPPLEMENT

Observation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Glutamine

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Resource Glutamine 3x10 gr per day

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ozan Yazici

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Numune Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ozan Yazici, MD

Role: CONTACT

Phone: +90 312 5084610

Email: [email protected]

Nuriye Ozdemir, MD

Role: CONTACT

Phone: +90 312 5084601

Email: [email protected]

Facility Contacts

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Ozan Yazici, MD

Role: primary

Nuriye Ozdemir, MD

Role: backup

Other Identifiers

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031

Identifier Type: -

Identifier Source: org_study_id