Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

Mahidol University30 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Acute Kidney Injury

Interventions

MagnesiumDRUG

Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration

ControlOTHER

Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Outcomes

Primary Outcomes

Acute kidney injury

Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment

Time frame: 7 days after cisplatin administration

Secondary Outcomes

Nephrotoxicity

Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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