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OpenTrials
Completed

NCT Number: NCT02724514

Multi-Parametric Assessment of Breast Lymphedema

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-invasive image & bioimpedance based techniques

Other

Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.

Primary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Mar 31, 2016
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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