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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Patient Starting Bevacizumab, Cancer

Intervention / Treatment
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* Other: Biological samples
* Other: Blood pressure measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient starting bevacizumab treatment for cancer<br>Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer | Other: Biological samples<br>* Urine and blood samples<br>Other: Blood pressure measurement<br>* Home blood pressure self-measurement and hospital blood pressure measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home blood pressure measurement | 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 | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital blood pressure measurement | Standardized measurement of in-hospital blood pressure (systolic, diastolic) and heart rate during bevacizumab infusion | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks | 
| 24-hour proteinuria | Measurement of 24 hours proteinuria | before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, bevacizumab, blood pressure, proteinuria