NCT02808624

Brief Summary

This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

May 20, 2016

Last Update Submit

April 20, 2017

Conditions

Peripheral NeuropathyCancer

Keywords

Oxaliplatin, peripheral neuropathy, L-CARNOSINE

Outcome Measures

Primary Outcomes (1)

  • Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.

    The following markers will be measured by ELISA kits : Nrf2 induced oxidative stress pathways (GSH) NF-KB anti-inflammatory pathway (TNF- alpha) pro-apoptic signals (caspase 3)

    Three months

Secondary Outcomes (1)

  • Assessment of tumor markers (CA,CEA) in blood.

    Three months

Study Arms (2)

Treatment group

EXPERIMENTAL

this arm will receive L-CARNOSINE PO (each patient will receive 1 tablet daily and each tablet contains 500 mg thus a total of 500 mg per day) together with their chemotherapy wich is oxaliplatin.

Drug: L-CARNOSINE

Control group

NO INTERVENTION

This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only.

Interventions

L-CARNOSINEDRUG

L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.

Also known as: CARNOSINE
Treatment group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are eligible to be enrolled in this study, if they meet the following criteria
  • Elderly males and females with age (˃18 and ˂60).
  • Cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months.

You may not qualify if:

  • Excluded from this study are the patients with the following Criteria:
  • Suffering from diabetes mellitus.
  • Suffering from peripheral neuropathy as a result of any other disease or drug.
  • Suffering from severe renal impairment (CrCl ˂ 30 ml/min).
  • Suffering from epilepsy.
  • Taking vitamin B.
  • Who previously took Oxaliplatin or any other chemotherapeutic agent that causes peripheral neuropathy.
  • Taking antidepressants or MAOI's.
  • Taking NSAIDs, paracetamol, opiates or any other analgesics or pain killers.
  • Pregnant or lactating patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Kasr El Aini, Egypt

Location

MeSH Terms

Conditions

Peripheral Nervous System DiseasesNeoplasms

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

NeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsDipeptidesOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Samira Saleh, Professor

    Cairo University

    STUDY DIRECTOR

  • Hanan elabhar, Professor

    Cairo University

    STUDY CHAIR

  • Mona Schaalan, assoc. prof.

    Misr International University

    STUDY CHAIR

  • Amr Shafik, Assoc. Prof

    Ain Shams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 22, 2016

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

EG(1)