Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

NCT ID: NCT02481518

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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).

Detailed Description

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

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Magnesium

Magnesium preloading group : Magnesium preloading for Cisplatin treatment

Group Type EXPERIMENTAL

Magnesium

Intervention Type DRUG

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

Control

Control group : Normal saline preloading for cisplatin treatment

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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Magnesium

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

Intervention Type DRUG

Control

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

Intervention Type OTHER

Other Intervention Names

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Normal saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arkom Nongnuch, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi hospital, Mahidol university

Locations

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Faculty of medicine, Ramathibodi Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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2558/172

Identifier Type: -

Identifier Source: org_study_id

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