Preloading Magnesium Attenuate Cisplatin-induced Nephroto... | NCT02481518

Studies
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

NCT02481518

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Aug 20, 2019Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Acute Kidney Injury

Interventions

Magnesium
Control

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

May 17, 2015

First Submission Date that Met QC Criteria

Jun 24, 2015

First Posted Date

Jun 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2019

Last Update Posted Date

Aug 20, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium	Experimental	Magnesium preloading group : Magnesium preloading for Cisplatin treatment	Drug: Magnesium
Control	Active Comparator	Control group : Normal saline preloading for cisplatin treatment	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute kidney injury	Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment	7 days after cisplatin administration

Secondary Outcomes

Measure	Description	Time Frame
Nephrotoxicity	Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)	up to 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arkom Nongnuch, MD	Ramathibodi hospital, Mahidol university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine, Ramathibodi Hospital, Mahidol University		Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008274	Magnesium
D000077330	Saline Solution

Ancestor Terms

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light

Browse Leaves

Not provided

Browse Branches

Not provided