Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium

NACompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

June 30, 2018

Study Completion Date

June 30, 2018

Conditions
Breast NeoplasmsEndothelial DysfunctionCardiovascular DiseaseMetabolic Syndrome
Interventions
PROCEDURE

Venous occlusion plethysmography

To characterize endothelial function in vivo the effect of vasodilatating substances is measured in the forearm circuit. The substances is administered via a thin catheter placed in the Brachial artery near the elbow in local anesthesia. Once the vessels dilate, the blood flow in the forearm will increase and the flow change is a measure of the vasodilatory capacity of that substance. The change is measured with classical venous occlusion plethysmography. The method described is established at Aarhus University Hospital and has been used for several decades to illustrate the effect of vasoactive drugs on the human circulation, meaning it is a proven and well documented method.

PROCEDURE

SphygmoCor

"Applanation tonometry (pulse wave velocity and central blood pressure/arterial stiffness): The central blood pressure and the augmentation index is estimated from the shape of the radial pulse wave measured with a tonometer.~Pulse wave velocity (PWV) is calculated from the average difference between the pulse pressure wave measured with a tonometer and the R in an ECG recorded simultaneously."

PROCEDURE

24hour blood pressure

24 hour blood pressure measurement

PROCEDURE

DEXA scan

Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).

BIOLOGICAL

Laboratory blood samples

"Fasting blood tests are drawn from an antecubital placed catheter (albumin, ALAT/ASAT, alkaline phosphatase, bilirubin, gammaglutamyl transferase, coagulation factors, red and white blood cells, creatinin, potassium, sodium, fasting lipids, fasting glucose, hemoglobin A1C, insulin, sex hormones, von Willebrand factor, low grade inflammation markers, DNA and RNA for later analyses, including relevant coding genes).~Further more urine samples to determine possible systemic impact of cardiovascular disease.~We will create a biobank containing urine and blood samples from participants for future research, provided that the participant gives her permission.~Responsibility for the biobank lies with the project responsible physician, Anders Bonde Jensen."

Trial Locations (1)

8000

Aarhus University Hospital, Aarhus

All Listed Sponsors
collaborator

Danish Cancer Society

OTHER

lead

University of Aarhus

OTHER

NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium | Biotech Hunter | Biotech Hunter