Clinical trial NCT03842917: SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)
Official title: SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Starting Bevacizumab
Cancer
Keywords: Cancer
bevacizumab
blood pressure
proteinuria
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid cancers who will be starting treatment with bevacizumab as part of the standard treatment

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

Eligibility criteria: 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

Primary outcomes:
measure: Home blood pressure measurement
timeFrame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
Secondary outcomes:
measure: in-hospital blood pressure measurement
timeFrame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
measure: 24-hour proteinuria
timeFrame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
Other outcomes:
Locations:
city: Tours
country: France
facility: Medical Oncology Service, University Hospital, Tours
city: Tours
country: France
facility: Oncological Gastroenterology Service, University Hospital, Tours
city: Tours
country: France
facility: Pneumology, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Theodora BEJAN-ANGOULVANT, MD-PhD
role: STUDY_DIRECTOR
References: