Multi-Parametric Assessment of Breast Lymphedema

Breast Cancer Clinical Trial

Official title:

Multi-Parametric Assessment of Breast Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724514
• Other study ID #: UHN REB 14-8503-C
• Status: Completed
• Start date: January 2015
• Est. completion date: January 3, 2019

Study information

• Verified date: November 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 3, 2019
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Lymphedema
• Lymphedema

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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