NCT03842917

SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria. This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.

Detailed description

Participants will be invited to participate to this research study by their oncologist within 1 to 2 weeks before starting bevacizumab treatment, as part of standard treatment. They will finish the research at the end of the third infusion of bevacizumab. Patients will perform a home blood pressure self-measurement over three days and will collect urine over 24 hours prior to the start of each bevacizumab infusion at cycles 1, 2 and 3. Blood pressure measurements will also be performed during each bevacizumab infusion and blood tests will be performed before each infusion to measure the following biomarkers: * Salt consumption as estimated by 24-hour natriuresis measured before each of the first 3 infusions * 24 hours aldosterone excretion measured before the first and third infusions * plasma methoxylated derivatives measured before the first and third infusions * NTproBNP measured before the first and third infusions * 24 hours urinary free cortisol measured before the first and third infusions * bevacizumab trough concentration measured before the first three bevacizumab infusion

Conditions

• Patient Starting Bevacizumab
• Cancer

Interventions

Type	Name	Description
OTHER	Biological samples	Urine and blood samples
OTHER	Blood pressure measurement	Home blood pressure self-measurement and hospital blood pressure measurement

Timeline

• Start date: 2019-04-26
• Primary completion: 2022-04-27
• Completion: 2022-06-15
• First posted: 2019-02-15
• Last updated: 2022-11-08

Locations

3 sites across 1 country: France