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Breast CancerPhase 2/3NCT02794324

The HeartSpare Study (Stage I)

A Phase 2/3 study testing Voluntary deep-inspiratory breath hold and Prone treatment in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Voluntary deep-inspiratory breath hold and Prone treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteUnited Kingdom
Study dates
Feb 2012to May 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
Voluntary deep-inspiratory breath hold, Active-breathing-controlled deep-inspiratory breathhold, Prone treatment
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voluntary deep-inspiratory breath holdProcedure or surgery

    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-breathing-controlled deep-inspiratory breathholdProcedure or surgery

    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.

  • Prone treatmentProcedure or surgery

    Patients undergoing scanning in a prone position will lie on a customised prone treatment platform. CT images will be acquired under free-breathing conditions.

  • Active-breathing-controlled deep-inspiratory breathholdDevice

    Also called Active Breathing Coordinator (Elekta, Crawley, UK)

    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.

Study groups in NCT02794324
Study groupRoleWhat they receive
Voluntary deep-inspiratory breath holdExperimentalStage 1A: Voluntary deep-inspiratory breath hold (v_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC_DIBH)
Receives: Procedure: Voluntary deep-inspiratory breath hold
Active-breathing-controlled deep-inspiratory breathholdActive comparatorStage 1A: Voluntary deep-inspiratory breath hold (v_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC_DIBH)
Receives: Procedure: Active-breathing-controlled deep-inspiratory breathhold; Device: Active-breathing-controlled deep-inspiratory breathhold
Prone treatmentActive comparatorStage 1B: Optimised supine DIBH vs prone position
Receives: Procedure: Prone treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interfraction reproducibility of chest wall position (group A)

    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.

    Measured: End of radiotherapy (3-4 weeks)

  2. Difference in mean left anterior descending coronary artery (LAD) mean normal tissue dose (NTDmean) (group B)

    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.

    Measured: End of radiotherapy (3-4 weeks)

Secondary outcomes (9)

  1. Difference in NTDmean for heart, LAD, ipsilateral and whole lungs (group A)

    Measured: End of radiotherapy (3-4 weeks)

  2. Comparison of standard deviation in mean LAD NTDmean over a treatment course (group B)

    Measured: End of radiotherapy (3-4 weeks)

  3. Comparison of individual patient heart NTDmean differences by anatomical factors (group B)

    Measured: End of radiotherapy (3-4 weeks)

  4. Difference in mean normal tissue doses (NTDmean) to heart, ipsilateral and whole lungs (group B)

    Measured: End of radiotherapy (3-4 weeks)

  5. Difference in volumes of chest wall receiving 20Gy (Groups A and B)

    Measured: End of radiotherapy (3-4 weeks)

  6. Interfraction reproducibility of chest wall position (groups A and B)

    Measured: End of radiotherapy (3-4 weeks)

  7. Interfraction reproducibility of tumour bed position (groups A and B)

    Measured: End of radiotherapy (3-4 weeks)

  8. Time and equipment costs (groups A and B)

    Measured: End of study (2 years)

  9. Patient and radiographer satisfaction with positioning technique (groups A and B)

    Measured: Weekly questionnaire

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2016 (estimated)
  2. Study startFeb 2012
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02794324
Sponsor's protocol ID
CCR3593
Status last verified
Jun 2016
First submitted
28 Oct 2011
Last updated
9 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Voluntary deep-inspiratory breath hold and Prone treatment in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interfraction reproducibility of chest wall position (group A) (time frame: End of radiotherapy (3-4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02794324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016; AzTrials last refreshed its copy on 5 Nov 2026.

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