NICaS device in Herceptin patients – PHASE I, version 2.0_ 22/11/2015

• Research type

  Research Study

• Full title

  The accuracy, efficacy and reproducibility of the whole body bio-impedance in cardiac output monitoring in Herceptin patients using, a Non Invasive Cardiac output monitoring System (NICaS) – PHASE I

• IRAS ID

  190963

• Contact name

  Paul Leeson

• Contact email

  Paul.Leeson@cardiov.ox.ac.uk

• Sponsor organisation

  University of Oxford

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Herceptin treatment has an increased risk of developing heart muscle damage which is one of the most serious complications of cancer treatment.

  As breast cancer survival is increasing with the earlier diagnosis and improved treatment, heart muscle damage due to chemotherapy, remains clinically important.

  The accuracy of the available methods of heart assessment in Herceptin patients is limited by a number of factors such as the cost, the complexity and the accuracy.

  This study is being carried out to compare the accuracy of a new system for monitoring the heart function non invasively called NICaS (a computer based system) to the current method of assessing the heart function using the heart ultrasound (Echocardiography- Echo). We are also aiming to determine the NICaS criterion of what is a significant drop in the heart function, by comparing the NICaS parameters to the drop in parameters measured by Echo.

  Study visits will coincide with hospital visits for Herceptin session and /or Echo scans over a period of 6 months.
  
  At every hospital or home visit (see PIS) for either Echo or Herceptin session the following will be checked and performed:
  -Height (1st visit only), weight and blood pressure
  -ECG (1st visit only)
  -Blood sample for BNP and Troponin level (1st visit only).
  -Sodium level and full blood count (performed as part the routine care). If no recent (within 3 months) blood results are available, a blood sample will be taken.
  -Medical and drug history.
  -A physical examination.
  -Documentation in CRF

  At every Echocardiogram scan visit (every 3 months) we will:

  -Perform a NICaS test in addition to the Echo scan; measurement will be taken within 30 minutes of the scan.

  At every Herceptin session (in hospital or at home every 3 weeks):

  -Monitor the heart using the NICaS just before Herceptin administration .

  No extra visits are expected so there will be no reimbursement for travel expenses.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  15/SC/0638

• Date of REC Opinion

  11 Dec 2015

• REC opinion

  Further Information Favourable Opinion