The HeartSpare Study (Stage I)

NCT ID: NCT02794324

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-05-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Voluntary deep-inspiratory breath hold

Stage 1A: Voluntary deep-inspiratory breath hold (v\_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC\_DIBH)

Group Type: EXPERIMENTAL

Voluntary deep-inspiratory breath hold

Intervention Type: PROCEDURE

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 breathhold

Stage 1A: Voluntary deep-inspiratory breath hold (v\_DIBH) vs Active-breathing-controlled deep-inspiratory breathhold (ABC\_DIBH)

Group Type: ACTIVE_COMPARATOR

Active-breathing-controlled deep-inspiratory breathhold

Intervention Type: PROCEDURE

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.

Active-breathing-controlled deep-inspiratory breathhold

Intervention Type: DEVICE

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.

Prone treatment

Stage 1B: Optimised supine DIBH vs prone position

Group Type: ACTIVE_COMPARATOR

Prone treatment

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Active Breathing Coordinator (Elekta, Crawley, UK)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Kirby

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

United Kingdom

Other Identifiers

CCR3593

Identifier Type: -

Identifier Source: org_study_id