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

Cancer Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842917
• Other study ID #: RIPH3-RNI18/SAVE
• Secondary ID: 2018-A03137-48
• Status: Completed
• Start date: April 26, 2019
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 15, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Patient Starting Bevacizumab
• Proteinuria

Intervention

Other:
• Biological samples
Urine and blood samples
• Blood pressure measurement
Home blood pressure self-measurement and hospital blood pressure measurement

Locations

Country	Name	City	State
France	Medical Oncology Service, University Hospital, Tours	Tours
France	Oncological Gastroenterology Service, University Hospital, Tours	Tours
France	Pneumology, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	24-hour proteinuria	Measurement of 24 hours proteinuria	before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks