Title: Support, Positioning and Organ Stabilisation during Breast Cancer Radiation Therapy: SuPPORT 4 All Bra
Funder: Department of Health and Social Care

Abstract: Background Breast cancer is the most common female malignancy worldwide with over 1.3 million diagnosed in 2008. For many the primary treatment is local excision (LE) followed by external beam radiotherapy to the whole breast. More women are surviving breast cancer (estimated to be 1.7 million by 2040) hence are living with the side effects of treatment. The breast is a mobile structure currently positioning errors may occur day-to-day. Errors have consequences on the distribution of dose in the breast, potentially increasing the risk of a loco-regional recurrence or the risk of fibrosis with subsequent cosmetic effects; poor cosmesis has a deleterious effect on patients body image and quality of life. Incidental irradiation of the lung and heart during radiotherapy can have long-term costs; the rate of major coronary events increases by 7.4% for each 1 Gray in mean radiation dose received by the heart. Reducing mean heart dose to 1 Gray is expected to reduce deaths from ischemic heart disease from around 9000 to 2000. Current cardiac avoidance techniques either shield the heart at the expense of breast coverage or take double the time to deliver compared with standard techniques. We propose to use a specially designed support bra that will ensure accurate breast irradiation, improvements in target coverage and reductions in dose to organs at risk (OAR) especially in women with larger breasts, while simultaneously providing modesty for patients. Many women are known to have body image concerns following breast surgery and the manipulation required to position the breast for treatment can be undignified. Aim and Purpose: To refine, produce and undertake testing (including CE marking for class 1 device) on a support bra for immobilising breast tissue during radiotherapy for women diagnosed with breast cancer (that have undergone a wide local excision leaving an intact breast). To produce a novel cost-minimum support bra that can, improve treatment accuracy, reduce dose to OAR and provide dignity. Method Workpackage 1 Design Refinement- Following filing for patent for the existing prototype an iterative co-design process (collaboration with user representatives and HCPs) will inform refinements to the support bra design. Using the existing prototype and electronic visuals (to model bra function) stakeholder discussions with the design team will highlight perceived barriers that may inhibit patient compliance or widespread adoption and minimise downstream difficulties in application. Four co-design workshops will be undertaken in total. Workpackage 2 Technical Testing-The refined prototype will be manufactured (in sizes extra-small, small, medium, large and extra-large) and will undergo experimental testing using breast phantoms to establish reproducibility and ability to reduce dose to OAR (lung and heart). Further tests with healthy volunteers (n=20) using stereophotogrammetry will assess functionality of the bra across a range of breast cup sizes. Running alongside workpackages 1 and 2 will be the regulatory procedures required to enable CE marking of the product ahead of patient safety testing. Workpackage 3 Health Economics and Service Integration-Simulation of treatment positioning with healthy volunteers (n&asymp;5) will identify potential process or service modifications required ahead of clinical implementation. Health Economics, service integration and commercialisation (running in tandem with Workpackage 1 and 2) will define the economic benefits of using a support bra for breast irradiation. A commercialisation plan will be initiated as part of this workpackage and implemented by the technology transfer team (lead Georgia Hatzigiannidou) at Sheffield Hallam University Workpackage 4 Clinical Testing-50 patients will be recruited for testing, and to collect data for economic analysis. Stratified randomisation will be adopted to enable a range of breast volumes to be studied for safety and accuracy purposes. See detail in Appendix

Lay abstract: Breast cancer affects a substantial proportion of the population (over 41,000 women were diagnosed with breast cancer in England in 2010 accounting for over 30% of all female cancers[5]. The main treatment for breast cancer is surgery, where surgery has involved removal of the lump only retaining the whole breast, radiotherapy will be given to the breast after surgery. Traditionally this has been given using basic radiotherapy beams. New technology provides the opportunity to spare sensitive structures that lie close to the breast such as the lung and the heart (where the left breast is treated); these techniques require greater accuracy in patient positioning. Set up errors in positioning of the breast for treatment have consequences on the distribution of radiation dose within the breast[6]. Set-up errors may increase the risk of the cancer coming back within the breast[7]. Furthermore, the introduction of partial breast radiotherapy (treatment of the site of the lump only) through current clinical trials adds further importance to the need to stabilise the breast. Partial breast radiotherapy requires accurate treatment placement to ensure a good distribution of radiation across the small area treated to avoid poor cosmetic appearance or risk of the cancer coming back in the breast[8]. Hence it is important given these developments to investigate methods to stabilise the breast during treatment. Most radiotherapy centres rely on the use of permanent tattoos marked on the patient to position the patient under the radiotherapy beam. However, accuracy using this approach can be problematic[9] and the use of permanent tattoos is of concern to many patients[10].The aim of this study is to develop a support bra that will allow accurate positioning of the breast on a day to day basis, that is acceptable to patients and helps to maintain modesty during treatment.

Research activity codes: 5.3 MEDICAL DEVICES;5.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: CANCER AND NEOPLASMS