Status:
NOT_YET_RECRUITING
Early Intervention
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Heinz Family Foundation
Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema
Conditions:
Breast Cancer
Breast Cancer Treatment Related Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Detailed Description
This is a single arm pilot study of a compression sleeve intervention for patients at high risk of breast cancer-related lymphedema (BCRL). The compression sleeve will also include a novel sensor to c...
Eligibility Criteria
Inclusion
- Eligible participants will be female, \>/= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included.
- Eligible participants will demonstrate low volume swelling (RVC 5-\<10%) \>/=12 weeks postoperatively
- Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document.
- Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and/or regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC.
Exclusion
- Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation.
- Participants will not be eligible if they have been diagnosed and/or treated for BCRL.
- Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded.
- Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05326165
Start Date
May 1 2026
End Date
June 30 2027
Last Update
June 11 2025
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114