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This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
Full description
This is a single arm pilot study of a compression sleeve intervention for patients at high risk of breast cancer-related lymphedema (BCRL). The compression sleeve will also include a novel sensor to capture patient adherence to compression wear and pressure applied to the arm.
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:
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.
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40 participants in 1 patient group
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Central trial contact
Alphonse G Taghian, MD, PhD
Data sourced from clinicaltrials.gov
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