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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808624
• Other study ID #: PT(1451)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 20, 2016
• Last updated: April 20, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Kasr el Aini

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	Ain Shams University, Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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