Early Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital
About this trial
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Juzo Compression Sleeve and Glove
- Compression Sleeve Sensor
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Heinz Family Foundation
Collaborator
Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema
Collaborator
Olayan-Xefos Family Fund for Breast Cancer Research
Collaborator
Source ClinicalTrials.gov