Clinical trial NCT06900023: The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
Official title: The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Edema
Breast Lymphedema
Lymphedema, Breast Cancer
Lymphedema
Keywords: Breast Edema
Breast Swelling
Breast Lymphedema
Breast Edema Screening
Breast swelling after breast cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: All participants must meet the following 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

Primary outcomes:
measure: Tissue Dielectric Constant
timeFrame: Baseline
measure: Breast Ultrasound
timeFrame: Baseline
Secondary outcomes:
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
measure: Scar Assessment Tool
timeFrame: Baseline
measure: Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool
timeFrame: Baseline
measure: Clinical Examination - Pitting Edema
timeFrame: Baseline
measure: Clinical Examination - Peau d'orange
timeFrame: Baseline
measure: Clinical Examination - Tissue fibrosis
timeFrame: Baseline
measure: Clinical Examination - Tenderness to palpation
timeFrame: Baseline
measure: Clinical Examination - Erythema
timeFrame: Baseline
measure: Clinical Examination - Scar localization
timeFrame: Baseline
measure: Clinical Examination - Visual fullness
timeFrame: Baseline
measure: Clinical Examination - Stemmer sign
timeFrame: Baseline
measure: Clinical Examination - Tissue thickening
timeFrame: Baseline
measure: Clinical Examination - Skin color changes
timeFrame: Baseline
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
measure: Patient-Reported Outcome Measures
timeFrame: Baseline
Other outcomes:
measure: Perometry
timeFrame: Baseline
measure: Bioimpedance Spectroscopy (SOZO)
timeFrame: Baseline
measure: Clinical Photographs
timeFrame: Baseline
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Cheryl Brunelle, MScPT
role: PRINCIPAL_INVESTIGATOR
References: