Breast biomechanics and bra support after surgery and radiotherapy.
Breast Cancer BRAs Study (Breast Cancer Biomechanics of Radiotherapy And Surgery): The Effects of Breast Surgery and Radiotherapy on the Breast Biomechanics and Breast Support Requirements of Women Treated for Breast Cancer.
We will test whether 3D scans and sensors can measure how surgery with or without radiotherapy changes breast movement and bra support needs in women treated for unilateral breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Locations | 1 site (Portsmouth) |
| Trial ID | NCT07135960 on ClinicalTrials.gov |
What this trial studies
Researchers at Portsmouth Hospitals and the University of Portsmouth will recruit women treated for unilateral breast cancer from Queen Alexandra Hospital and invite them to the University of Portsmouth biomechanics lab for testing after surgery and/or after radiotherapy, with an optional pre-surgery visit. The protocol uses 3D surface scans and wearable sensors to quantify breast shape and movement, comparing the treated breast to the contralateral breast as an internal control. Participants will complete short questionnaires about their bra requirements, exercise habits, and their experience of the testing procedures. The study excludes people with metastatic or bilateral disease, recent surgery or radiotherapy within the exclusion windows, active postoperative infection or dressings, pregnancy or breastfeeding, epilepsy, high frailty, or those requiring an interpreter.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with unilateral early or locally advanced breast cancer who have had or will have surgery with or without adjuvant radiotherapy and can travel to the University of Portsmouth biomechanics laboratory and provide informed consent.
Not a fit: People with metastatic or bilateral breast cancer, very recent surgery or radiotherapy within the exclusion timeframes, active postoperative breast infection or dressings, pregnancy or breastfeeding, epilepsy, high frailty, prior contralateral breast surgery, or who require an interpreter are not eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could lead to better-targeted bra and support recommendations that improve comfort, reduce tissue strain, and enhance quality of life after breast cancer treatment.
How similar studies have performed: Biomechanics measurements have been used in healthy women and athletes, but applying these methods to guide bra support after breast cancer surgery or radiotherapy is largely novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * 18 years of age or above * Early or locally advanced breast cancer classified as B5a or B5b (radical treatment intent) * Unilateral breast cancer (contralateral breast used as control) * Receiving or has received breast cancer surgery * +/- Adjuvant radiotherapy * Able to travel to the University of Portsmouth Breast biomechanics laboratory * Participant has capacity to consent. Exclusion Criteria: * Metastatic breast cancer diagnosis * \< 2 weeks post-operative * \< 4 weeks post-radiotherapy * Active post-operative breast infection * Requirement of ongoing breast dressings * Previous breast surgery to contralateral breast * Bilateral breast cancer * Epilepsy (due to strobe on 3D scanner) * Pregnancy or \<6 weeks post-partum * Breastfeeding * Rockwood Frailty score \>5 (or those unable to ambulate un-aided) * Requiring interpreter.
Where this trial is running
Portsmouth
- Queen Alexandra Hospital — Portsmouth, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Edward St John — Portsmouth Hospitals NHS Trust
- Study coordinator: Amy Huseyin
- Email: Amyrose.Huseyin@porthosp.nhs.uk
- Phone: 02392 286000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.