Breast Cancer BRAs Study (Breast Cancer Biomechanics of Radiotherapy And Surgery)
ConditionBreast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorPortsmouth Hospitals NHS Trust
About this trial
This study, delivered by Portsmouth Hospitals University NHS Trust in conjunction with the Research Group in Breast Health at the University of Portsmouth \[1\], aims to assess whether it is possible to test breast biomechanics in women who have had surgery with or without radiotherapy for the treatment of breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Metastatic breast cancer diagnosis
< 2 weeks post-operative
< 4 weeks post-radiotherapy
Active post-operative breast infection
Trial population
Female patients, aged \>18, who have a diagnosis of early breast cancer, and are offered breast surgery +/- adjuvant radiotherapy as part of their breast cancer treatment.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 2 trial groupsGroup A: Participants with relevant condition
Group B: Women aged 18 or treated with surgery +/- radiotherapy for breast cancer that affects one of their b
Trial outcomes
Primary outcomes
1
To determine the feasibility of recruitment to a breast biomechanics study in women treated for early breast cancer with surgery +/- adjuvant radiotherapy.
To identify: Number of patients eligible. Number of patients approached. Number of patients who give informed consent. Number of patients who withdraw after consent before participation. Number of patients who withdraw during follow-up. Number of patients lost to follow-up. Completeness of data per participant. Barriers to participation
Time frame
From enrollment to the end of study [through study completion, an average of 1 year]Secondary outcomes
1
To determine if it is possible to obtain breast biomechanics data in women treated for early breast cancer with surgery +/- adjuvant radiotherapy.
To collect quantitative data on breast biomechanics. To assess: Sensitivity of data collection methods to detect differences in breast biomechanics pre-operatively to post-operatively and/or between left breast and right breast.
Time frame
From enrollment to the end of study [through study completion, an average of 1 year]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Portsmouth Hospitals NHS Trust
Lead sponsor
University of Portsmouth
Collaborator
Source ClinicalTrials.gov