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NCT Number: NCT02808624

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

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) .

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Key information

Conditions

Peripheral Neuropathy Cancer Neoplasms Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cairo University

Cairo, Kasr El Aini, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-Carnosine

Drug

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

Other names: CARNOSINE

Primary outcomes

  1. Assessment of peripheral neuropathy using neuropathy grading score "CTCAE", version 4.0) also oxidative stress markers will be measured by ELISA kits.

    Time frame: 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 outcomes

  1. Assessment of tumor markers (CA,CEA) in blood.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ain Shams University
  • Misr International University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2016
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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