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L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT02808624
Collaborator
Misr International University (Other), Ain Shams University (Other)
65
Enrollment
1
Location
2
Arms
18
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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) .

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Oxaliplatin causes peripheral neuropathy , L-CARNOSINE is supposed to prevent this side effect possibly by reducing oxidative stress and enhancing the growth of nerves.This study is intended to clarify the effect and mechanism of action of L-CARNOSINE in preventing Oxaliplatin induced peripheral neuropathy in cancer patients.

Blood samples will be collected from the patients before starting the chemotherapy and at the end of treatment duration (3 months) and then oxidative stress markers will be measured in these samples

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

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
L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.
Other Names:
  • CARNOSINE

    		•
    No Intervention: Control group

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

    Outcome Measures

    Primary Outcome Measures

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

      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)

    Secondary Outcome Measures

    1. Assessment of tumor markers (CA,CEA) in blood. [Three months]

      Tumor Markers (CA,CEA) will be assessed at the end of treatment duration to make sure that L-CARNOSINE didn't interfere with the patients' response to chemotherapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients are eligible to be enrolled in this study, if they meet the following criteria

    1. Elderly males and females with age (˃18 and ˂60).

    2. Cancer patients treated with oxaliplatin for the first time (dose 85- 135mg/m2) administered every two to three weeks for 3 months.

    Exclusion Criteria:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Kasr el Aini Egypt

    Sponsors and Collaborators

    • Cairo University
    • Misr International University
    • Ain Shams University

    Investigators

    • Study Director: Samira Saleh, Professor, Cairo University
    • Study Chair: Hanan elabhar, Professor, Cairo University
    • Study Chair: Mona Schaalan, assoc. prof., Misr International University
    • Study Chair: Amr Shafik, Assoc. Prof, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rana Magdy, Teaching assistant, Misr International University
    ClinicalTrials.gov Identifier:
    NCT02808624
    Other Study ID Numbers:
    • PT(1451)
    First Posted:
    Jun 22, 2016
    Last Update Posted:
    Apr 24, 2017
    Last Verified:
    Apr 1, 2017
    Keywords provided by Rana Magdy, Teaching assistant, Misr International University
    Oxaliplatin, peripheral neuropathy, L-CARNOSINE
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Apr 24, 2017