Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05586009 |
| Other study ID # |
35629/8/22 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
October 2022 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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].
Description:
This study aims to:
- Investigate the potential role of magnesium in prevention of cisplatin induced
nephrotoxicity in patient with head and neck cancer.
- Determine the optimal dose of magnesium (Mg).
Study Design :
- This is a randomized, controlled, parallel, prospective clinical study included 75
patients with head and neck cancer presented and treated at Clinical Oncology Department
Tanta University Hospital, Tanta.
- This study will be approved by Research Ethics Committee of Tanta University.
- Randamization will be carried out based on days of hospital admission.
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:
- Group 1 (n=25): receive cisplatin with hydration 500 mg magnesium (8 Meq) .
- Group 2 (n=25): receive cisplatin with hydration 1000 mg magnesium (16 Meq).
- Group 3 (n=25): receive cisplatin with hydration 2000 mg magnesium (32 Meq). Blood and
urine sample will be drawn before and after treatment (7 cycles ).
For all patients the following will be performed:
1. Full history and physical examination.
2. Demographic data (patient weight, ideal body weight (IBW) and Body surface area (BSA)
determination).
3. Renal function testing ( blood urea nitrogen (BUN), serum creatinine (SrCr), BUN/SrCr
ratio, estimated glomerular filtration rate (eGFR), sodium (Na) level and magnesium (Mg)
level ).
4. Nephrotoxicity will be defined according to common terminology criteria for adverse
events version 5.00 (CTCAE) (U.S. Department Of Health And Human Services.,2017).
5. Measuring health-related quality of life.
6. Laboratory, radiologically, and endoscopic examination for oncological diagnosis.
7. Estimation level of Urinary neutrophil gelatinase associated lipocalin (NGAL), Urinary
kidney injury molecule - 1( KIM - 1) and Serum soluble Fasl at baseline and within five
days of the last cisplatin dose administration.
8. Liver function tests (AST and ALT) before and after treatment (7 cycle).
Provision of Privacy :
- Privacy of all data is guaranated and there will be a file with code number for every
patient and include all investigations.
- All patients will give their written informed consents.
- Data of all patients will be private and confidential.
- Any unexpected risks appeared during the course of the research will be reported to
patients and ethical committee on time.
