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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Patient Starting Bevacizumab
• Intervention / Treatment: Other: Biological samples; Other: Blood pressure measurement

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

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Medical Oncology Service, University Hospital, Tours
  • Tours, France, 37044
    • Oncological Gastroenterology Service, University Hospital, Tours
  • Tours, France, 37044
    • Pneumology, University Hospital, Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with solid cancers who will be starting treatment with bevacizumab as part of the standard treatment

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient starting bevacizumab treatment for cancer; Taken biological samples (urine and blood) and blood pressure measurement on patients starting bevacizumab treatment for cancer	Other: Biological samples; Urine and blood samples; Other: Blood pressure measurement; Home blood pressure self-measurement and hospital blood pressure measurement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Theodora BEJAN-ANGOULVANT, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; proteinuria; bevacizumab; blood pressure
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria
• Other Study ID Numbers: RIPH3-RNI18/SAVE; 2018-A03137-48 (Other Identifier: IdRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No