The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer

NCT06900023 | Enrolling By Invitation

• 1 other identifier: 23412
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer. Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.

Conditions

Breast Edema; Breast Lymphedema; Lymphedema, Breast Cancer; Lymphedema

Keywords

Breast Edema; Breast Swelling; Breast Lymphedema; Breast Edema Screening; Breast swelling after breast cancer

Outcome Measures

Primary Outcomes (2)

• Tissue Dielectric Constant

  A TDC interbreast ratio ≥ 1.28 in any quadrant will be used as an indicator of breast lymphedema

  Baseline

• Breast Ultrasound

  Skin thickness \>1.60 mm in superior and lateral quadrants, \>2.0 mm in the medial and inferior quadrants will be used as an indicator of breast lymphedema.

  Baseline

Secondary Outcomes (19)

• Patient-Reported Outcome Measures

  Baseline

• Patient-Reported Outcome Measures

  Baseline

• Scar Assessment Tool

  Baseline

• Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool

  Baseline

• Clinical Examination - Pitting Edema

  Baseline

Other Outcomes (3)

• Perometry

  Baseline

• Bioimpedance Spectroscopy (SOZO)

  Baseline

• Clinical Photographs

  Baseline

Study Arms (2)

Participants with breast edema: N=15

This group will contain women who report breast edema and have been diagnosed with breast edema through clinical examination

Participants without breast edema: N=15

These participants do not report a history of breast edema and do not have a history of breast edema.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women screened for lymphedema in the MGH Lymphedema Research Program Prospective Screening Program; and/or women treated in physical or occupational therapy for breast cancer-related conditions after breast conserving surgery.

You may qualify if:

• Be a female between the ages of 18 and 85 years.
• Have undergone breast conserving surgery +/- LN removal (sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
• Have no residual cancer in the breast after definitive breast surgery
• Have been treated with radiation therapy and have completed breast cancer treatment (excluding Herceptin and hormonal treatments) at MGH greater than or equal to 3 months ago.
• Be able to read and understand English
• Understand the proposed study and be willing and fully able to comply with the study procedures
• Be a willing participant and be capable of giving and has given informed written consent for entry into the study

You may not qualify if:

• Participants will be excluded if they:
• Have bilateral BC
• Have metastatic or inflammatory BC
• Will be excluded from the SOZO measurement of the study if they have implanted cardiac devices or neurostimulators
• Have any medical condition that may result in breast swelling;
• Uncontrolled congestive cardiac failure,
• Arteriovenous haemodialysis,
• Current infection or cellulitis of either breast.
• Be pregnant or currently breast feeding.
• Have a known over-active thyroid or known benign thyroid tumour

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheryl Brunelle, MScPT

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Clinical Specialist, Associate Director, MGH Lymphedema Research Program

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 28, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)