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The goal of this clinical trial is to assess the efficacy of glutamine in preventing the occurrence of vincristine induced neuropathy and to compare the reduction in rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between those who treated with glutamine and those who did not.
Participants will:
receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for 14 consecutive days from d 1 of induction and 14 days from d1 of continuation .
• Subjects will be asked to return for a complete study assessments visit every 14-days during supplementation period for a total of 4 visits Keep a diary of their symptoms of neuropathy and compliance to treatment and any adverse event
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | Thirty five patients will receive glutamine in a dose of 6 g /m2 twice daily (up to a maximum of 10 g/dose) for forteen consecutive days starting from induction and forteen days starting from d1 of continuation . The dose used in the current study is determined by prior adult studies described a significant beneficial effect of glutamine on oxaliplatin and paclitaxel-induced peripheral neuropathy (Wang et al., 2007) |
|
| Standard of care arm | No Intervention | the usual standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine (Pharmacological doses) | Drug | glutamine is an essential amino acid. It will be provided in a powder form. It will be dissolved in at least 8 ounces of hot or cold liquid. It can also be mixed with a soft food such as pudding |
| Measure | Description | Time Frame |
|---|---|---|
| safety outcome | The primary safety endpoint was the the number of participants who will report bleeding tendency episodes and number of participants with significant impairment of liver or kidney functions | 12 months |
| primary objective outcome | the number of participants who develop neuropathy | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nihal hussien aly mostafa, assistant professsor of pediat | Contact | +201001053961 | nihal.hussien.ali@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Cairo Governorate | 11517 | Egypt |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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A block-randomization scheme will be generated by computer software. Patients fulfilling the inclusion criteria will then be randomly distributed between glutamine and the standard of care therapy in a 1:1 ratio.
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| D021542 | Amino Acids, Neutral |