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Trial record 1 of 1 for:    NCT02881203
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Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart (BRAVEHeart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881203
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sydney

Brief Summary:
This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Breathe Well Device: RPM Not Applicable

Detailed Description:

Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed <50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%.

Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
Actual Study Start Date : September 15, 2018
Actual Primary Completion Date : September 30, 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Breathe Well + RPM
Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Device: Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.

Device: RPM
Varian Real-time Position Management (RPM) system

Active Comparator: RPM
Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.
Device: RPM
Varian Real-time Position Management (RPM) system




Primary Outcome Measures :
  1. Accuracy of Breathe Well [ Time Frame: 2 years ]
    The accuracy will be measured by comparing 'Breathe Well' and RPM measurements with images acquired of the breast during the radiation treatment using an electronic portal imaging device (EPID).


Secondary Outcome Measures :
  1. Difference in set up times for Breathe Well vs RPM [ Time Frame: 2 years ]
    The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions.

  2. Patient comfort [ Time Frame: 2 years ]
    To investigate patient comfort in using 'Breathe Well' via a patient survey.

  3. Staff perception of Breathe Well [ Time Frame: 2 years ]
    To investigate staff perception of 'Breathe Well' via a technology assessment survey.

  4. To develop the use of EPID for real time MLC tracking during breast radiotherapy [ Time Frame: 2 years ]
  5. To compare actual and planned doses [ Time Frame: 2 years ]
    Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Left-sided breast cancer patients (invasive and in situ)
  • Supine positioning of the patients.
  • Ability to perform a ≥20s breath hold
  • >18 years old
  • An ECOG score in the range of 0 to 2
  • Able to give written informed consent and willingness to participate and comply with the study
  • Patients must be able to read and complete questionnaires in English

Exclusion Criteria:

  • Involvement or at risk regional lymph nodes
  • Pregnant / lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881203


Locations
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Australia, New South Wales
Gillian Lamoury
St Leonards, New South Wales, Australia, 2065
Sponsors and Collaborators
University of Sydney
Investigators
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Principal Investigator: Gillian Lamoury, Medicine Royal North Shore Hospital
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02881203    
Other Study ID Numbers: BRAVEHeartV1
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sydney:
breast cancer
radiation
DIBH
cardiac toxicity
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases