Early Intervention
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT05326165
- Status
- Not Yet Recruiting
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Conditions
- Breast Cancer
- Breast Cancer Treatment Related Lymphedema
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Juzo Compression Sleeve and Glove — DEVICEElasticized garment sized for arm and hand to create pressure to reduce swelling
- Compression Sleeve Sensor — DEVICESmall device embedded within compression sleeve garment collecting usage information
Study Details
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Key Dates
- Start date
- May 31, 2026
- Status verified
- May 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Compression therapyParticipants 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.
Primary Outcome Measure
Arm Volume [ Time Frame: 1, 3, 6, 9 and 12 months ]
Central Contacts
- Alphonse G Taghian, MD, PhD617-726-6050
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | Alphonse G Taghian, MD PhD (PRINCIPAL_INVESTIGATOR) |
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