NCT02024191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

December 25, 2013

Last Update Submit

December 30, 2013

Conditions

Peripheral Neuropathy

Keywords

glutamineoxaliplatinperipheral neuropathy

Outcome Measures

Primary Outcomes (1)

  • Electromyography parameters

    Electromyography action potential values will be compared between two patient groups.

    4 months interval

Secondary Outcomes (1)

  • Neurological signs and symptoms

    4 months

Study Arms (2)

Glutamine

EXPERIMENTAL

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

Dietary Supplement: Glutamine

Observation

NO INTERVENTION

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

Interventions

GlutamineDIETARY_SUPPLEMENT
Also known as: Resource Glutamine 3x10 gr per day
Glutamine

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients who had chemotherapy in last 6 months
  • Diabetes Mellitus
  • Sensorimotor polyneuropathy
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Numune Education and Research Hospital

Ankara, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Central Study Contacts

Ozan Yazici, MD

CONTACT

+90 312 5084610drozanyazici@gmail.com

Nuriye Ozdemir, MD

CONTACT

+90 312 5084601nyozdemir@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 25, 2013

First Posted

December 31, 2013

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

TU(1)