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

Study Overview
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Brief Summary
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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
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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

Official Title
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The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients

Conditions
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Peripheral Neuropathy, Cancer

Intervention / Treatment
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* Drug: L-CARNOSINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.<br>* Other names: CARNOSINE;|
| No Intervention: Control group<br>This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxaliplatin, peripheral neuropathy, L-CARNOSINE