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

NCT ID: NCT06900023

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2027-12-31

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.

Detailed Description

The goal of this observational study is to learn if the study protocol is feasible, if we can accrue participants easily, and to determine how well two tools (tissue dielectric constant and ultrasound) identify breast edema after breast conserving surgery for breast cancer.

Participants will be asked to attend one appointment in which all data will be collected. This will include questionnaires regarding symptoms, clinical examination, measurement of breast edema using two tools (ultrasound and tissue dielectric constant), measurement with the perometer and SOZO, and clinical photographs.

Conditions

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

Study Design

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

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Brunelle

Physical Therapy Clinical Specialist, Associate Director, MGH Lymphedema Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl Brunelle, MScPT

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

23412

Identifier Type: -

Identifier Source: org_study_id