Multi-Parametric Assessment of Breast Lymphedema

November 25, 2019 updated by: University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast lymphedema Cancer patients with lymphedema

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema
Time Frame: 2 years
The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
2 years
Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema
Time Frame: 2 years
The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Robert Dinniwall, MD, UHN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 3, 2019

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 24, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 14-8503-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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