Back to resultsL-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients
Primary Purpose
Peripheral Neuropathy, Cancer
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
L-CARNOSINE
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Neuropathy focused on measuring Oxaliplatin, peripheral neuropathy, L-CARNOSINE
Eligibility Criteria
Inclusion Criteria:
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.
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
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.
This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Assessment of tumor markers (CA,CEA) in blood.
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.
Full Information
NCT ID
NCT02808624
First Posted
May 20, 2016
Last Updated
April 20, 2017
Sponsor
Cairo University
Collaborators
Misr International University, Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT02808624
Brief Title
L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients
Official Title
The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Misr International University, Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. 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) .
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Cancer
Keywords
Oxaliplatin, peripheral neuropathy, L-CARNOSINE
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only.
Intervention Type
Drug
Intervention Name(s)
L-CARNOSINE
Other Intervention Name(s)
CARNOSINE
Intervention Description
L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.
Primary Outcome Measure Information:
Title
Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.
Description
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)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Assessment of tumor markers (CA,CEA) in blood.
Description
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.
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samira Saleh, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanan elabhar, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mona Schaalan, assoc. prof.
Organizational Affiliation
Misr International University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amr Shafik, Assoc. Prof
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Kasr el Aini
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
L-carnosine Prophylactic Effect on Oxaliplatin Induced Peripheral Neuropathy in GIT Cancer Patients
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