NCT05326165

Early Intervention

Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.

Detailed 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: 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

• Breast Cancer
• Breast Cancer Treatment Related Lymphedema

Interventions

Type	Name	Description
DEVICE	Juzo Compression Sleeve and Glove	Elasticized garment sized for arm and hand to create pressure to reduce swelling
DEVICE	Compression Sleeve Sensor	Small device embedded within compression sleeve garment collecting usage information

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2022-04-13
• Last updated: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study