The HeartSpare Study (Stage I)

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Voluntary deep-inspiratory breath hold; Procedure: Prone treatment; Device: Active-breathing-controlled deep-inspiratory breathhold

• Registration Number: NCT02794324
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study Start: 2012-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-08
• Last Update Submitted: 2016-06-08
• Study First Posted: 2016-06-09
• Last Update Posted: 2016-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Voluntary deep-inspiratory breath hold	Voluntary deep-inspiratory breath hold	Stage 1A: Voluntary deep-inspiratory breath hold (v_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC_DIBH)
Prone treatment	Prone treatment	Stage 1B: Optimised supine DIBH vs prone position
Active-breathing-controlled deep-inspiratory breathhold	Active-breathing-controlled deep-inspiratory breathhold	Stage 1A: Voluntary deep-inspiratory breath hold (v_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC_DIBH)

Primary Outcome Measures

Name	Time	Method
Interfraction reproducibility of chest wall position (group A)	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.
Difference in mean left anterior descending coronary artery (LAD) mean normal tissue dose (NTDmean) (group B)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, United Kingdom