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

Phase 1

Completed

• Conditions: Peripheral Neuropathy; Cancer
• Interventions: Drug: L-CARNOSINE

• Registration Number: NCT02808624
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-22
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	L-CARNOSINE	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Kasr el Aini, Egypt