Effect van een zoutbeperkt dieet op de bloeddrukstijging die door behandeling met sunitinib of regorafenib kan ontstaan Subtitel:Preventie van bijwerkingen vanVEGF-remmers door zoutbeperking (SUN-SALT studie)

• Conditions: Hypertension; VEGF inhibitor-induced toxicity; renal carcinoma; thyroid carcinoma; hepatocellular carcinoma; gastrointestinal stroma cell tumor

• Registration Number: NL-OMON24531
• Lead Sponsor: ErasmusMC University Medical Center Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

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 day average at 24h ABPM or <140/90 mmHg office)

Exclusion Criteria

•Not providing informed consent or not capable of giving informed consent

•Using antihypertensive drugs other than a calcium channel blocker at baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean difference in blood pressure rise between the treatment cycle with and the treatment cycle without salt restriction.

Secondary Outcome Measures

Name	Time	Method
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.