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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Cancer; Patient Starting Bevacizumab

Treatments: Other: Biological samples; Other: Blood pressure measurement

Study type: Observational

Funder types: Other

Identifiers

NCT03842917

RIPH3-RNI18/SAVE

2018-A03137-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient
• With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization

Exclusion criteria

• Renal cancer
• Recent changes in antihypertensive treatment(s) in the last month, with the exception for diuretics where treatment stability of at least 3 months will be required
• Patients who do not wish to participate to the study

Trial design

26 participants in 1 patient group

Patient starting bevacizumab treatment for cancer

Description:

Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer

Treatment:

Other: Biological samples

Other: Blood pressure measurement