Clinical trial NCT02724514: Multi-Parametric Assessment of Breast Lymphedema
Official title: Multi-Parametric Assessment of Breast Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Lymphedema
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast lymphedema Cancer patients with lymphedema

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* At least 18 y/o
* Diagnosis of lymphedema involving the breast
* Diagnosis of in-situ or invasive breast cancer
* Female patients following breast conserving therapy and radiotherapy
* Spoken and written fluency in English; and
* Able to provide informed consent

Exclusion Criteria:

* Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis
* Prior breast surgery on the contra lateral breast
* Presence of active cellulitis within the breast, trunk or arm and
* Presence of active cancer

Primary outcomes:
measure: Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema
timeFrame: 2 years
measure: Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: UHN
name: Robert Dinniwall, MD
role: PRINCIPAL_INVESTIGATOR
References: