Cancer, Patient Starting Bevacizumab
Conditions
Keywords
Cancer, bevacizumab, blood pressure, proteinuria
Brief 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
Interventions
OTHERBiological samples
Urine and blood samples
OTHERBlood pressure measurement
Home blood pressure self-measurement and hospital blood pressure measurement
Sponsors
University Hospital, Tours
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Home blood pressure measurement | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks | Home blood pressure (systolic, diastolic) before each bevacizumab infusion, as the mean of 3 measures in the morning and 3 measures in the evening, over 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| in-hospital blood pressure measurement | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks | Standardized measurement of in-hospital blood pressure (systolic, diastolic) and heart rate during bevacizumab infusion |
| 24-hour proteinuria | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks | Measurement of 24 hours proteinuria |
Countries
France
Outcome results
None listed