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The goal of this [ type of study: intervential study is to compare between different doses of magnesium to prevent cisplatin induced nephrotoxicity.] In 75 participant population with head and neck cancer recieved cisplatin it aims to answer are: • • optimal doses of magnesium as 3 groups each group take 1gm of magnesium then second group take 2gm of magnesium and finally third group take 3gm of magnesium Researchers will compare [ 3 groups ] to see if [ magnesium has effects in prevention cisplatin nephrotoxicity].
This study aims to:
Study Design :
Treatment Protocol :
• All patients will be scheduled to receive the standard treatment of head and neck cancer. Concurent chemo radio therapy (CCRT) consisting of radiotherapy, cisplatin (40mg / m²) by intravenous infusion) . This regimen will be repeated weekly for 7 cycles .
Patients will be classified into three groups:
For all patients the following will be performed:
Provision of Privacy :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | (n=25): receive cisplatin with hydration 1000mg magnesium (8 q) intravenous infusion ( IVI ). |
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| Group 2 | Active Comparator | (n=25): receive cisplatin with hydration 2000mg magnesium (16 Meq) ( IVI ). |
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| Group 3 | Active Comparator | (n=25): receive cisplatin with hydration 3000 mg magnesium (32 Meq) ( IVI ). |
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| Group 4 | Placebo Comparator | Group 4 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin with hydration magnesium | Drug | Optimal doses of magnesium in prevention cisplatin induced nephrotoxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 75 patients received magnesium with Treatment related Adverse Events as Assessed by CTCAE v5.0 At the end of cycle 7 of chemotherapy (each cycle is 7days) | Optimal doses of magnesium | At the end of cycle 7 of chemotherapy (each cycle is 7days) |
| Measure | Description | Time Frame |
|---|---|---|
| 75 patients received magnesium and access change of biomarkers levels From Baseline in nephrotoxicity at the end of cycle 7 of chemotherapy (each cycle is 7days) | Kim-1, NGAL, FasL and MDA | At the end of cycle 7 of chemotherapy (each cycle is 7days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamed Saad younis | Tanta | Gharbia Governorate | 0000 | Egypt |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| cisplatin 40 mg/m² | Drug | Group 1 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week). |
|