Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity (PRAGMATIC)

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Magnesium; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02481518

2558/172

Details and patient eligibility

About

The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).

Full description

Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Eastern Cooperative Oncology Group score 0-2
• First Diagnosed Head and neck cancer and plan for treatment with cisplatin
• Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)

Exclusion criteria

• Prior treatment with cisplatin before randomization
• Uncontrolled concurrent disease
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Magnesium

Experimental group

Description:

Magnesium preloading group : Magnesium preloading for Cisplatin treatment

Treatment:

Drug: Magnesium

Control

Active Comparator group

Description:

Control group : Normal saline preloading for cisplatin treatment

Treatment:

Other: Control