UnknownNot Applicable

Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration

Thailand100 participantsStarted 2023-03-07

Plain-language summary

The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cancer patient who has plan to receive first cycle of cisplatin \>= 60 mg/m2 * Normal serum creatinine and creatinine clearance \>= 50 ml/min * Age \< 75 years old * Serum albumin \>= 3 g/dl * Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist Exclusion Criteria: * The patient who receives other chemotherapy with adminstration volume higher than 500 ml * Prior heart failure or known left ventricular ejection fraction \> 50% * Prior renal dysfunction within 3 months * Uncontrolled renal disease * current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

renal dysfunction at least grade 1 following cisplatin treatment in short hydration group

Timeframe: from starting cisplatin to 4-week after cisplatin discontinuation

Trial details

NCT IDNCT05884905

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-07

Contact for this trial

Suthinee Ithimakin, MD

+66898127440 aesi105@yahoo.co.th

View on ClinicalTrials.gov More Renal Insufficiency trials