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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-26

Study Completion Date

2022-06-15

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.

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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

Conditions

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Patient Starting Bevacizumab Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient starting bevacizumab treatment for cancer

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

Biological samples

Intervention Type OTHER

Urine and blood samples

Blood pressure measurement

Intervention Type OTHER

Home blood pressure self-measurement and hospital blood pressure measurement

Interventions

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Biological samples

Urine and blood samples

Intervention Type OTHER

Blood pressure measurement

Home blood pressure self-measurement and hospital blood pressure measurement

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No