The Effect of Prehydration on the Pharmacokinetics of Low-dose Cisplati

Phase 4

Completed

• Conditions: cancer; malignancy; Tumor; 10027655

• Registration Number: NL-OMON42571
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Scheduled for concurrent low-dose cisplatin and radiotherapy
- > 18 years old
- GFR > 60
- able to provide informed consent

Exclusion Criteria

- Prior treatment with platinum compounds
- Poor kidney function (GFR <60)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is a difference in pharmacokinetics (Cmax and AUC) of<br /><br>cisplatin. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary study parameter is a difference in platinum-DNA adducts in white<br /><br>blood cells and a difference in urinal excretion of cisplatin.</p><br>