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

November 7, 2022 updated by: University Hospital, Tours

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Urine and blood samples
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
Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
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
Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
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
Time Frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
Measurement of 24 hours proteinuria
before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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