SuPPORT 4 All Clinical Feasibility Trial
Research type
Research Study
Full title
Support, Positioning and Organ stabilisation during Breast Cancer Radiation Therapy: The SuPPORT 4 All project.
IRAS ID
196147
Contact name
Heidi Probst
Contact email
Sponsor organisation
Sheffield Hallam University
Duration of Study in the UK
0 years, 6 months, days
Research summary
Currently women undergoing breast radiotherapy are treated naked from the waist upwards with no immobilisation of the breast; despite the breast being a mobile structure. We have developed a bra (the Support 4 All bra – S4A) to support, and help position the breast for radiotherapy to ensure the breast remains in the same position each day, improving the accuracy of treatment. The bra has several potential benefits for women undergoing radiotherapy following a diagnosis of breast cancer as follows:\n1.\tThe bra provides lift for women with larger breasts removing tissue folds at the side and at the base of the breast. This should reduce skin reactions from radiotherapy, particularly where the breast overhangs on to the chest.\n2.\tThe lift provided for women with larger breasts may help healthcare staff improve the distribution of radiation dose within the breast and may reduce the radiation dose received by the lung (and the heart where the left breast is being treated). \n3.\tThe support bra may enable women to be planned and treated with fewer permanent tattoos than are currently used to mark the patient for set up.\n4.\tThe support bra should improve modesty by avoiding the need for women to completely undress.\nWhat the trial will do\nThis trial will test how practical it is for women to wear the S4A bra during radiotherapy, and how easy it is for the radiographers to use the bra to help them position the patient underneath the radiotherapy machine each day. The trial will compare:\n•\tTwenty five women treated in the S4A bra with\n•\tTwenty five women treated without the S4A bra\nThe radiotherapy will be planned and delivered as normal, there will no changes made to the radiotherapy.\nWhat will happen next?\nIf the trial is successful the S4A bra will be made available to all women having radiotherapy where they still have their breast after surgery. There maybe a further larger trial to accurately measure the benefits of the bra in a larger group of women.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0236
Date of REC Opinion
18 May 2017
REC opinion
Further Information Favourable Opinion