A study that investigates whether short hydration is a better option to prevent kidney damage than long hydration during cisplatin chemotherapy in patients with head and neck cancer.
Phase 1
- Conditions
- Cisplatin induced nephrotoxicityTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003890-23-NL
- Lead Sponsor
- Erasmus MC Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 226
Inclusion Criteria
Age =18 years;
All patients with diagnosed head and neck cancer with a standard of care indication for chemo radiation with weekly cisplatin 40 mg/m2 (CHEMORAD) treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46
Exclusion Criteria
Prior treatment with cisplatin.
Unable to give written informed consent according to the International Council for Harmonisation-Good clinical practice (ICH-GCP) and national / local regulations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method