Cancer, Hypertension
Conditions
Brief summary
Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most common side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.
Interventions
DRUGBevacizumab
Intra-arterial infusion during 6 minutes
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Male 18-50 years old * normal results of glucose, lipids and creatinine * informed consent
Exclusion criteria
* History of abuse of drugs or alcohol * History of malignant disease * First degree relatives with a history of cancer before the age of 50 * First degree relatives with a history of premature cardiovascular disease * Current use of medication * Clinical evidence of cardiac of pulmonary disease * Hypertension ( systolic\>140mmHg, diastolic \>90mmHg) * Diabetes mellitus * smoking * a history of thombosis or a family history of recurrent thrombosis * abnormality on ECG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio | Infusion of bevacizumab during 6 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab | Infusion of bevacizumab during 6 minutes |
Countries
Netherlands
Outcome results
None listed