Early Intervention (NCT05326165) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Intervention
United States40 participantsStarted 2026-05
Plain-language summary
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 d…