NCT02794324

The HeartSpare Study (Stage I)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2016-06-09
• Last updated: 2016-06-09

Locations

1 site across 1 country: United Kingdom