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Multi-Parametric Assessment of Breast Lymphedema

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ClinicalTrials.gov Identifier: NCT02724514
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment
Breast Cancer Breast Lymphedema Other: non-invasive image & bioimpedance based techniques

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Parametric Assessment of Breast Lymphedema
Study Start Date : January 2015
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema


Intervention Details:
  • Other: non-invasive image & bioimpedance based techniques
    Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.


Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast lymphedema Cancer patients with lymphedema
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724514


Contacts
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Contact: Robert Dinniwell, MD 416 946 4501 ext 4662 Rob.Dinniwell@rmp.uhn.on.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Robert Dinniwall, MD UHN

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02724514     History of Changes
Other Study ID Numbers: UHN REB 14-8503-C
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases