Comparative Study of Different Doses of Magnesium as a Protective Agent in Nephrotoxicity in Cancer Patients

NCT05586009 | Completed Phase 2 FDA Drug

• 1 other identifier: 35629/8/22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 \[ magnesium has effects in prevention cisplatin nephrotoxicity\].

Conditions

Cisplatin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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)

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)

  At the end of cycle 7 of chemotherapy (each cycle is 7days)

Study Arms (4)

Group 1

ACTIVE COMPARATOR

(n=25): receive cisplatin with hydration 1000mg magnesium (8 q) intravenous infusion ( IVI ).

Drug: cisplatin with hydration magnesium

Group 2

ACTIVE COMPARATOR

(n=25): receive cisplatin with hydration 2000mg magnesium (16 Meq) ( IVI ).

Drug: cisplatin with hydration magnesium

Group 3

ACTIVE COMPARATOR

(n=25): receive cisplatin with hydration 3000 mg magnesium (32 Meq) ( IVI ).

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).

Drug: cisplatin 40 mg/m²

Interventions

cisplatin with hydration magnesium DRUG

Optimal doses of magnesium in prevention cisplatin induced nephrotoxicity

Group 1; Group 2; Group 3

cisplatin 40 mg/m² DRUG

Group 1 (control group) (n=25): received cisplatin 40 mg/m² only for 7 cycles (1 cycle = 1 week).

Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with head and neck cancer recieved cisplatin ECOG \<2 eGFR\>59 ml/min/1.73 Adequate hematological parameters

You may not qualify if:

• pregnant and lactating women Using of nephrotoxic drugs as NSAIDs Patients with hypersensitivity to any drug used Diabetic patients Patients with cardiovascular diseases

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mohamed Saad younis

Tanta, Gharbia Governorate, 0000, Egypt

Location

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: October 1, 2022
• Primary Completion: February 27, 2025
• Study Completion: March 30, 2025
• Last Updated: March 23, 2026

Record last verified: 2023-12

Locations

EG (1)