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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02808624

Enrollment

Registered

2016-06-22

Start date

2015-06-30

Completion date

2016-12-31

Last updated

2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Peripheral Neuropathy

Keywords

Oxaliplatin, peripheral neuropathy, L-CARNOSINE

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

Interventions

DRUGL-CARNOSINE

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026