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| Name | Class |
|---|---|
| Misr International University | OTHER |
| Ain Shams University | OTHER |
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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) .
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
|
| Control group | No Intervention | This arm wont receive L-CARNOSINE, they will receive their chemotherapy (oxaliplatin) only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-CARNOSINE | Drug | L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients are eligible to be enrolled in this study, if they meet the following criteria
Exclusion Criteria:
Excluded from this study are the patients with the following Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samira Saleh, Professor | Cairo University | Study Director |
| Hanan elabhar, Professor | Cairo University | Study Chair |
| Mona Schaalan, assoc. prof. | Misr International University | Study Chair |
| Amr Shafik, Assoc. Prof | Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Kasr El Aini | Egypt |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002336 | Carnosine |
| ID | Term |
|---|---|
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004151 | Dipeptides |
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| D009842 |
| Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |