Multi-Parametric Assessment of Breast Lymphedema

NCT ID: NCT02724514

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-01-03

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.

Conditions

Breast Cancer; Breast Lymphedema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

non-invasive image & bioimpedance based techniques

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dinniwall, MD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 14-8503-C

Identifier Type: -

Identifier Source: org_study_id