Prevention of VEGF inhibitor-induced toxicity by salt restricto
Completed
- Conditions
- All malignancies for which sunitinib or regorafenib is an authorised therapy1003836410057166
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
• Registered indication for sunitinib or regorafenib in the standard treatment regime 4 weeks treatment and 2 weeks off (sunitinib) or 3 weeks on/1 week off (regorafenib).
• Blood pressure well controlled at baseline (<135/85 mmHg at 24h ABPM or <140/90 mmHg office)
• Written informant consent
• Age >= 18 years,
Exclusion Criteria
• Not providing informed consent or not capable of giving informed consent
• Using antihypertensive drugs other than a calcium channel blocker at baseline
• Weight loss of 10% or more in the previous six months indicating undernutrition
• Insufficient understanding of Dutch language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean difference in blood pressure rise between the treatment cycle with and the<br /><br>treatment cycle without salt restriction. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Effects of salt restriction on rise in endothelin-1, proteinuria as marker for<br /><br>nephropathy and pharmacokinetics of sunitinib and regorafenib; if an effect on<br /><br>blood pressure is shown, further analyses of effects on renal transporter<br /><br>proteins will be performed to explain the mechanism of salt sensitivity.</p><br>