The HeartSpare Study (Stage I)

June 8, 2016 updated by: Royal Marsden NHS Foundation Trust

Optimisation and Individualisation of Heart-Sparing Breast Radiotherapy Techniques (The HeartSpare Study)

Radiotherapy (RT) has a major curative role in women with early breast cancer, and is recommended routinely after lumpectomy and selectively after mastectomy. It has contributed to a halving of breast cancer mortality in the UK over the last 2 decades despite ever-rising cancer incidence. RT in women with left-sided tumours often exposes the underlying heart to a damaging dose. The heart is very sensitive to RT, and there were 1-2 deaths from heart disease for every 100 breast cancer patients treated during the 1960s-70s. The situation has improved in recent years, but standard RT techniques still deliver significant radiation doses to heart tissue.

Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in deeply and to hold their breath for about 20 seconds while RT is given. The downward movement of the diaphragm pulls the heart away from the RT beam. In the other technique, women lie on their fronts, instead of on their backs as they normally do for breast RT. In this position, the breast falls away from the rib cage and reduces exposure of the heart. Neither technique is routinely available to women receiving breast RT in the UK for reasons that this research aims to address. The investigators need to: 1) confirm that patient position can be reproduced with millimetre precision every day using these techniques, 2) minimise costs of equipment, time and personnel required to support such techniques, 3) select the most appropriate technique for different patients and 4) train staff in centres across the UK to deliver techniques safely and effectively. By addressing all of these issues, the study aims ultimately to make heart-sparing RT available to all UK women that might benefit from treatment, thereby significantly reducing the burden of heart disease in breast cancer survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) of the left breast following breast conservation surgery or mastectomy.
  • Recommendation for whole breast (groups A and B) or chest wall (Group A only) radiotherapy (with or without tumour bed boost)
  • Age ≥18
  • Performance status ≤1
  • Patients able to tolerate breath-hold

Exclusion Criteria:

  • Requirement for nodal irradiation
  • Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance
  • Previous radiotherapy to any region above the diaphragm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Voluntary deep-inspiratory breath hold
Stage 1A: Voluntary deep-inspiratory breath hold (v_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC_DIBH)
Procedure: Voluntary deep-inspiratory breath hold
Patients undergoing scanning in v_DIBH will be positioned supine with arms extended on a MedTec breast board. They will be monitored visually on screen and will be given a buzzer to press when they have taken a breath. CT images will be obtained during DIBH. If the patient needs to release their breath, they will be asked to press the buzzer a second time. Patients will be closely monitored by radiographers via CCTV.
ACTIVE_COMPARATOR: Active-breathing-controlled deep-inspiratory breathhold
Stage 1A: Voluntary deep-inspiratory breath hold (v_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC_DIBH)
Procedure: Active-breathing-controlled deep-inspiratory breathhold
Patients undergoing scanning in ABC_DIBH will be positioned supine with arms extended on a MedTec breast board to which an activated-breathing control device (Elekta, Crawley, UK) has been attached. They will breathe through the device. During ABC_DIBH, CT images will be obtained.
Device: Active-breathing-controlled deep-inspiratory breathhold
The ABC unit allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. The device consists of a mouthpiece connected to a pneumotachometer via a bidirectional valve and tubing. The air flow across the pneumotachometer is integrated and displayed on a computer monitor. The computer also controls a scissor valve which, when enabled, restricts air flow through the system, enabling the breath hold phase. The mouthpiece and air filter are patient specific, as is a nose clip that is used to ensure that patients are breathing through the device.
Other Names:
  • Active Breathing Coordinator (Elekta, Crawley, UK)
ACTIVE_COMPARATOR: Prone treatment
Stage 1B: Optimised supine DIBH vs prone position
Procedure: Prone treatment
Patients undergoing scanning in a prone position will lie on a customised prone treatment platform. CT images will be acquired under free-breathing conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interfraction reproducibility of chest wall position (group A)
Time Frame: End of radiotherapy (3-4 weeks)
The position of ipsilateral chest wall will be compared between the digitally reconstructed radiographs (derived from the planning CT) and the on-treatment electronic portal images and mean daily displacements calculated.
End of radiotherapy (3-4 weeks)
Difference in mean left anterior descending coronary artery (LAD) mean normal tissue dose (NTDmean) (group B)
Time Frame: End of radiotherapy (3-4 weeks)
Using dose-volume histograms (DVHs) based on the planning scan and on-treatment CBCT imaging, mean LAD NTDmean will be compared for ABC_DIBH versus prone positioning.
End of radiotherapy (3-4 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in NTDmean for heart, LAD, ipsilateral and whole lungs (group A)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Comparison of standard deviation in mean LAD NTDmean over a treatment course (group B)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Comparison of individual patient heart NTDmean differences by anatomical factors (group B)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Difference in mean normal tissue doses (NTDmean) to heart, ipsilateral and whole lungs (group B)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Difference in volumes of chest wall receiving 20Gy (Groups A and B)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Interfraction reproducibility of chest wall position (groups A and B)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Interfraction reproducibility of tumour bed position (groups A and B)
Time Frame: End of radiotherapy (3-4 weeks)
End of radiotherapy (3-4 weeks)
Time and equipment costs (groups A and B)
Time Frame: End of study (2 years)
End of study (2 years)
Patient and radiographer satisfaction with positioning technique (groups A and B)
Time Frame: Weekly questionnaire
Weekly questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

June 8, 2016

First Posted (ESTIMATE)

June 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CCR3593

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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