Early Intervention

Starting soon · Not applicable

Conditions studied: Breast Cancer, Breast Cancer Treatment Related Lymphedema

In brief

This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.

Key facts

Study ID

NCT05326165

Run by

Massachusetts General Hospital

People needed

40

Starts

2027-05-01

Expected to finish

2027-06-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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