Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
NCT Number: NCT02724514
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema.
The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.
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Notify Me18 year and older
Female
Observational
Toronto, Ontario, M5G 2M9, Canada
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Limited research has been conducted on the frequency of breast lymphedema with most studies reporting the incidence as ranging from 33 to 48%. Women with breast lymphedema describe breast fullness, heaviness and pain associated with breast swelling and changes that impacts how the breast looks (cosmesis) and also impacts their quality of life.
At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life.
The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication.
Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.
Time frame: 2 years
The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
Time frame: 2 years
The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
University Health Network, Toronto
Other
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