Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-05-31
2027-06-30
Brief Summary
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Detailed Description
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This research is being done because patients receiving lymph node surgery and lymph node radiation for breast cancer are at risk of lymphedema on the arm, trunk or breast/chest wall on the side of treatment. There is some evidence that compression sleeves may prevent progression of early swelling to lymphedema. This study is looking to determine if:
1. a compression garment worn for four weeks helps to prevent breast cancer-related lymphedema (BCRL) in those at high risk of BCRL
2. a sensor attached to the sleeve is accurately measuring time worn and pressure applied
3. participants are wearing the compression for the prescribed time, and if not, what are the barriers to wear
4. participants adhere to the study schedule for filling out patient surveys regarding symptoms and satisfaction with screening.
Findings from this study will apply to the development of a larger randomized controlled trial to examine if compression prevents progression to BCRL for patients with low volume swelling.
Study procedures include screening for eligibility, treatment including evaluations and follow up visits. Study treatment will last for four weeks with follow up at one, three, six, nine and 12 months.
It is expected that about 40 people will take part in this research study.
This study is receiving financial support from the Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema (AG Taghian); the Olayan-Xefos Family Fund for Breast Cancer Research (AG Taghian), and the Heinz Family Foundation (AGTaghian).
Juzo Inc. is supporting this research study by providing compression garments and a Juzo pressure monitor. Impedimed Inc is supporting this study by providing a Sozo bioimpedance measurement device for research use.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Compression therapy
Participants will receive a ready to wear compression sleeve and glove with embedded sensor.
Compression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks.
Participants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.
Juzo Compression Sleeve and Glove
Elasticized garment sized for arm and hand to create pressure to reduce swelling
Compression Sleeve Sensor
Small device embedded within compression sleeve garment collecting usage information
Interventions
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Juzo Compression Sleeve and Glove
Elasticized garment sized for arm and hand to create pressure to reduce swelling
Compression Sleeve Sensor
Small device embedded within compression sleeve garment collecting usage information
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Heinz Family Foundation
UNKNOWN
Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema
UNKNOWN
Olayan-Xefos Family Fund for Breast Cancer Research
UNKNOWN
Massachusetts General Hospital
OTHER
Responsible Party
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Alphonse Taghian
Principal Investigator
Principal Investigators
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Alphonse G Taghian, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-600
Identifier Type: -
Identifier Source: org_study_id
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