All malignancies for which sunitinib or regorafenib is an authorised therapy
Conditions
Interventions
A salt restricted diet (
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 (= 18 years,
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in blood pressure rise between the treatment cycle with and the treatment cycle without salt restriction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of salt restriction on rise in endothelin-1, proteinuria as marker for nephropathy and pharmacokinetics of sunitinib and regorafenib; if an effect on blood pressure is shown, further analyses of effects on renal transporter proteins will be performed to explain the mechanism of salt sensitivity. | — |
Countries
Netherlands
Outcome results
None listed