The nephroprotective effect of short hydration during cisplatin treatment in head and neck cancer patients.
Phase 4
Recruiting
- Conditions
- kidney damageNephrotoxicity1002765610038430
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 226
Inclusion Criteria
- Age >=18 years;
- Newly diagnosed head and neck cancer with a standard of care indication for
cisplatin 40 mg/m2
Q1W chemo radiation treatment
- Written informed consent according to the International Council for
Harmonisation-Good clinical
practice (ICH-GCP) and national / local regulations
- Ability to return to the Erasmus MC Cancer Institute for adequate follow-up
Exclusion Criteria
- Prior treatment with cisplatin.
- The presence of clinically relevant drug interactions according to the
current SmPC
- The presence of clinically relevant contra-indications according to the
current SmPC
- Hypersensitivity towards cisplatin or any of the excipients
- Pregnancy or lactation
- Chronic kidney disease
- Baseline eGFR < 60 ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The incidence acute kidney injury (AKI) grade >= 1 according to CTCAE v4.0<br /><br>criteria during cisplatin 40mg/m2 Q1W chemo radiation in patients with head and<br /><br>neck cancer using a long hydration scheme compared to patients using a short<br /><br>hydration scheme. </p><br>
- Secondary Outcome Measures
Name Time Method