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Completed

NCT Number: NCT03842917

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Oncology Service, University Hospital, Tours, Tours, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological Samples

Other

Urine and blood samples

Blood pressure measurement

Other

Home blood pressure self-measurement and hospital blood pressure measurement

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 24-hour proteinuria

    Time frame: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks

    Measurement of 24 hours proteinuria

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: SAVE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2019
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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