Bevacizumab and Endothelium Dependent Vasodilation

Sponsor
Radboud University Medical Center
Study ID
NCT01125943
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Acetylcholine — DRUG
    Intra-arterial infusion
  • Nitroprusside — DRUG
    Intra arterial infusion
  • Bevacizumab — DRUG
    Intra arterial infusion

Study Details

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs. The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.

Key Dates

First listed
May 19, 2010
Start date
Jun 30, 2010
Status verified
Jan 2013
Primary completion
Oct 31, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP

Arms

  • Experimental: Acetylcholine
    Intra-arterial infusion of acetylcholine in two increasing dosages during 5 minutes each during the intra-arterial infusion of bevacizumab
  • Experimental: Nitroprusside
    Infusion of two increasing dosages of nitroprusside during 5 minutes each during the continuous infusion of bevacizumab

Primary Outcome Measure

Vasomotor response assessed by venous occlusion strain gauge plethysmography [ Time Frame: 15 minutes ]

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