NCT02481518

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

May 17, 2015

Last Update Submit

August 18, 2019

Conditions

Acute Kidney Injury

Keywords

Cisplatin nephrotoxicityAcute kidney injury

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

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

    7 days after cisplatin administration

Secondary Outcomes (1)

  • Nephrotoxicity

    up to 12 weeks

Study Arms (2)

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

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

Magnesium
ControlOTHER

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

Also known as: Normal saline
Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

MagnesiumSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Arkom Nongnuch, MD

    Ramathibodi hospital, Mahidol university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2015

First Posted

June 25, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

TH(1)