Breast EdemaBEACONNCT06900023
The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
An observational study of Breast Edema and Breast Lymphedema, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Edema, Breast Lymphedema, Lymphedema, Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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
- Keywords
- Breast Edema, Breast Swelling, Breast Lymphedema, Breast Edema Screening, Breast swelling after breast cancer
- Medical subject headings
- Breast Cancer Lymphedema, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Dielectric Constant
A TDC interbreast ratio ≥ 1.28 in any quadrant will be used as an indicator of breast lymphedema
Measured: 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.
Measured: Baseline
Secondary outcomes (19)
Patient-Reported Outcome Measures
Breast Cancer Treatment Outcome Scale (BCTOS-12) Minimum Score = 12, Maximum Score = 48 Higher score indicates worse outcome
Measured: Baseline
Patient-Reported Outcome Measures
Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales i. Psychosocial Well-Being (min score 10, max score 50), higher score indicating better outcome
Measured: Baseline
Scar Assessment Tool
Patient and Observer Scar Scale Linear Scar Version 3.0
Measured: Baseline
Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool
This is a validated measure used to administer clinical examination of the breast, trunk and upper extremity for lymphedema
Measured: Baseline
Clinical Examination - Pitting Edema
The following will be assessed:
- Each breast quadrant: Presence or absence of pitting edema
- The participant is placed in supine. The examiner's thumb is placed firmly on the participant's skin, applying sustained pressure to the skin and superficial tissue for one minute. Upon release of the pressure, an indentation of the tissue at the test site is defined as pitting and is recorded as Yes in the relevant quadrant. If there is no change in the tissue, record No to pitting oedema.
Measured: Baseline
Clinical Examination - Peau d'orange
The following will be assessed:
- Each breast quadrant, lateral chest wall and inframammary tissues: Presence or absence of peau d'orange
- The participant is positioned sitting. The examiner slightly compresses the breast tissue between their first finger and thumb to look for the orange peel appearance to the skin. A light can be shone tangentially across the breast to assist in identifying peau d'orange.
Measured: Baseline
Clinical Examination - Tissue fibrosis
The following will be assessed:
- Each breast quadrant: Presence or absence of tissue fibrosis
- The participant is placed in supine. The examiner uses their first finger and thumb to palpate the tissue and gently pinch the tissue to assess for any tissue thickening, increased firmness or density and/or tissue retraction or fixation, compared to the equivalent tissue on the unaffected side. If the participant has had surgery on the unaffected breast (e.g. breast reduction), the tissue in the quadrant most distal to the incision site is used as the comparator tissue. N/A is marked in the table for the unaffected breast, unless the participant has had surgery on the unaffected side and tissue fibrosis is detected as a result compared to other quadrants of the unaffected breast.
Measured: Baseline
Clinical Examination - Tenderness to palpation
The following will be assessed:
- Each breast quadrant: Presence or absence of tenderness to palpation.
- The examiner will lightly palpate the tissue of each breast quadrant to see if the participant reports any pain or tenderness. Deep palpation, particularly medially in the breast, may cause tenderness in the costochondral cartilages.
Measured: Baseline
Clinical Examination - Erythema
The following will be assessed:
- Each breast quadrant: Presence or absence of erythema (redness of the skin)
Measured: Baseline
Clinical Examination - Scar localization
The following will be assessed:
- Scar measurements for the breast and axillary scars, including location (quadrant, distance from the center of the nipple to the center of the scar), scar length, width and orientation (vertical, horizontal, oblique or radial).
Measured: Baseline
Clinical Examination - Visual fullness
The following will be assessed:
- Lateral chest wall and inframammary tissue: The examiner will record presence or absence of visual fullness
Measured: Baseline
Clinical Examination - Stemmer sign
The following will be assessed:
- Lateral chest wall and inframammary tissue: Presence or absence of the Stemmer sign. The Stemmer sign is a physical examination finding used to diagnose lymphedema. If the examiner cannot pinch the skin then this positive finding is associated with lymphedema. The Stemmer sign has been found to be a sensitive predictor for primary and secondary lymphedema with moderate specificity (Goss JA, Greene AK. Sensitivity and Specificity of the Stemmer Sign for Lymphedema: A Clinical Lymphoscintigraphic Study. Plast Reconstr Surg Glob Open. 2019 Jun 25;7(6):e2295. doi: 10.1097/GOX.0000000000002295. PMID: 31624689; PMCID: PMC6635205)
Measured: Baseline
Clinical Examination - Tissue thickening
The following will be assessed by the examiner:
- Nipple and nipple-areolar complex: Tissue thickening on the side of surgery as compared to the unaffected side
Measured: Baseline
Clinical Examination - Skin color changes
The following will be assessed by the examiner:
- Nipple and nipple-areolar complex: Skin color changes as compared to the unaffected side (lighter, darker, same)
Measured: Baseline
Patient-Reported Outcome Measures
Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales ii. Sexual Well-Being (min score 6, max score 30), higher score indicating better outcome
Measured: Baseline
Patient-Reported Outcome Measures
Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales iii. Satisfaction with Breasts (min score 11, max score 44), higher score indicating better outcome
Measured: Baseline
Patient-Reported Outcome Measures
Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales iv. Physical Well-Being: Chest (min score 10, max score 30), higher score indicating better outcome
Measured: Baseline
Patient-Reported Outcome Measures
Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales v. Adverse Effects of Radiation (min score 6, max score 18), higher score indicating better outcome
Measured: Baseline
Patient-Reported Outcome Measures
Breast-Q Version 2.0 Breast Conserving Therapy Module, Postoperative Scales vi. Satisfaction with Information - Breast Surgeon (min score 12, max score 48), higher score indicating better outcome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start5 May 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast EdemaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Brunelle, Massachusetts General Hospital
- Investigators
- Cheryl Brunelle, MScPT, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900023
- Sponsor's protocol ID
- 23412
- Acronym
- BEACON
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT06900023
- Acronym / sponsor ID
- BEACON / 23412
- Conditions
- Breast Edema, Breast Lymphedema, Lymphedema, Breast Cancer, Lymphedema
- Keywords
- Breast Edema, Breast Swelling, Breast Lymphedema, Breast Edema Screening, Breast swelling after breast cancer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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;
- Be pregnant or currently breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tissue Dielectric Constant
Time frame: Baseline
A TDC interbreast ratio ≥ 1.28 in any quadrant will be used as an indicator of breast lymphedema
Breast Ultrasound
Time frame: Baseline
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.
19 secondary outcomes
Patient-Reported Outcome Measures
Time frame: Baseline
Patient-Reported Outcome Measures
Time frame: Baseline
Scar Assessment Tool
Time frame: Baseline
Clinical Examination of Lymphedema of the Upper Extremity Clinical Exam Tool
Time frame: Baseline
Clinical Examination - Pitting Edema
Time frame: Baseline
Clinical Examination - Peau d'orange
Time frame: Baseline
Clinical Examination - Tissue fibrosis
Time frame: Baseline
Clinical Examination - Tenderness to palpation
Time frame: Baseline
Clinical Examination - Erythema
Time frame: Baseline
Clinical Examination - Scar localization
Time frame: Baseline
Clinical Examination - Visual fullness
Time frame: Baseline
Clinical Examination - Stemmer sign
Time frame: Baseline
Clinical Examination - Tissue thickening
Time frame: Baseline
Clinical Examination - Skin color changes
Time frame: Baseline
Patient-Reported Outcome Measures
Time frame: Baseline
Patient-Reported Outcome Measures
Time frame: Baseline
Patient-Reported Outcome Measures
Time frame: Baseline
Patient-Reported Outcome Measures
Time frame: Baseline
Patient-Reported Outcome Measures
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Edema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Active, not recruitingPhase 2
Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
Breast Carcinoma, Breast Lump
Recruiting
Effect of Resisted Deep Breathing and Myofascial Release in Postmastectomy
Post Mastectomy Lymphedema
Active, not recruitingPhase 2
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
Edema, Erythema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheryl Brunelle, MScPT principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Edema and Breast Lymphedema, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Dielectric Constant (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.