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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

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) .

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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

Conditions

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Peripheral Neuropathy Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

L-CARNOSINE

Intervention Type DRUG

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

Control group

This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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L-CARNOSINE

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

Intervention Type DRUG

Other Intervention Names

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CARNOSINE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No