Cisplatin Adverse ReactionPhase 2NCT05586009
Comparative Study of Different Doses of Magnesium as a Protective Agent in Nephrotoxicity in Cancer Patients
A Phase 2 study testing cisplatin with hydration magnesium and cisplatin 40 mg/m² in people with Cisplatin Adverse Reaction, run by Tanta University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cisplatin Adverse Reaction
- What is being tested?
- cisplatin with hydration magnesium and cisplatin 40 mg/m²
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with head and neck cancer recieved cisplatin ECOG <2 eGFR>59 ml/min/1.73 Adequate hematological parameters
Who cannot join
- pregnant and lactating women Using of nephrotoxic drugs as NSAIDs Patients with hypersensitivity to any drug used Diabetic patients Patients with cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Different Doses of Magnesium as a Protective Agent in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer
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].
Read the detailed 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:
- Full history and physical examination.
- Demographic data (patient weight, ideal body weight (IBW) and Body surface area (BSA) determination).
- 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 ).
- 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).
- Measuring health-related quality of life.
- Laboratory, radiologically, and endoscopic examination for oncological diagnosis.
- 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.
- 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.
- Conditions
- Cisplatin Adverse Reaction
- Being tested
- cisplatin with hydration magnesium, cisplatin 40 mg/m²
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin with hydration magnesiumDrug
Optimal doses of magnesium in prevention cisplatin induced nephrotoxicity
cisplatin 40 mg/m²Drug
Group 1 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | (n=25): receive cisplatin with hydration 1000mg magnesium (8 q) intravenous infusion ( IVI ). Receives: Drug: cisplatin with hydration magnesium |
| Group 2 | Active comparator | (n=25): receive cisplatin with hydration 2000mg magnesium (16 Meq) ( IVI ). Receives: Drug: cisplatin with hydration magnesium |
| Group 3 | Active comparator | (n=25): receive cisplatin with hydration 3000 mg magnesium (32 Meq) ( IVI ). Receives: Drug: cisplatin with hydration magnesium |
| Group 4 | Placebo comparator | Group 4 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week). Receives: Drug: cisplatin 40 mg/m² |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of cycle 7 of chemotherapy (each cycle is 7days)
Secondary outcomes (1)
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
Measured: At the end of cycle 7 of chemotherapy (each cycle is 7days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Oct 2022
- Primary completion27 Feb 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed saad saad younis, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586009
- Sponsor's protocol ID
- 35629/8/22
- Status last verified
- Dec 2023
- First submitted
- 16 Oct 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Different Doses of Magnesium as a Protective Agent in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05586009
- Acronym / sponsor ID
- 35629/8/22
- Conditions
- Cisplatin Adverse Reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed 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:
- Full history and physical examination.
- Demographic data (patient weight, ideal body weight (IBW) and Body surface area (BSA) determination).
- 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 ).
- 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).
- Measuring health-related quality of life.
- Laboratory, radiologically, and endoscopic examination for oncological diagnosis.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: cisplatin with hydration magnesium(n=25): receive cisplatin with hydration 1000mg magnesium (8 q) intravenous infusion ( IVI ). |
| Group 2 | Active comparator | Drug: cisplatin with hydration magnesium(n=25): receive cisplatin with hydration 2000mg magnesium (16 Meq) ( IVI ). |
| Group 3 | Active comparator | Drug: cisplatin with hydration magnesium(n=25): receive cisplatin with hydration 3000 mg magnesium (32 Meq) ( IVI ). |
| Group 4 | Placebo comparator | Drug: cisplatin 40 mg/m²Group 4 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with head and neck cancer recieved cisplatin ECOG <2 eGFR>59 ml/min/1.73 Adequate hematological parameters
Key exclusion criteria (1 listed)
- pregnant and lactating women Using of nephrotoxic drugs as NSAIDs Patients with hypersensitivity to any drug used Diabetic patients Patients with cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin with hydration magnesiumOptimal doses of magnesium in prevention cisplatin induced nephrotoxicity | Drug | Group 1, Group 2, Group 3 |
| cisplatin 40 mg/m²Group 1 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week). | Drug | Group 4 |
Primary outcome
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)
Time frame: At the end of cycle 7 of chemotherapy (each cycle is 7days)
Optimal doses of magnesium
1 secondary outcome
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)
Time frame: At the end of cycle 7 of chemotherapy (each cycle is 7days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin with hydration magnesium and cisplatin 40 mg/m² in people with Cisplatin Adverse Reaction, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: At the end of cycle 7 of chemotherapy (each cycle is 7days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.