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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)

Prevention of VEGF inhibitor-induced toxicity by salt restriction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24531
Enrollment
16
Registered
2018-10-09
Start date
2018-10-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Salt restricted (<4g/day) diet

Sponsors

ErasmusMC University Medical Center Rotterdam
Lead Sponsor

Eligibility

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 (<135/85 mmHg day average at 24h ABPM or <140/90 mmHg office) • Written informant consent • Age &#8805; 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

MeasureTime frame
mean difference in blood pressure rise between the treatment cycle with and the treatment cycle without salt restriction.

Secondary

MeasureTime 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.

Contacts

Public ContactJorie Versmissen
j.versmissen@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)