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Studies

Interventional Not yet recruiting

NCT05326165 on ClinicalTrials.gov

Early Intervention

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

  • Sponsor: Massachusetts General Hospital
  • Collaborators: Heinz Family Foundation, Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema, Olayan-Xefos Family Fund for Breast Cancer Research
  • Enrollment: 40 (Estimated)
  • Study start: 2027-05-01 (Estimated)
  • Primary completion: 2027-06-30 (Estimated)
  • Study completion: 2027-06-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Supportive Care

Brief Summary

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

Conditions

  • Breast Cancer
  • Breast Cancer Treatment Related Lymphedema

Intervention / Treatment

  • Device: Juzo Compression Sleeve and Glove
  • Device: Compression Sleeve Sensor

Primary Outcome Measures

  • Arm Volume (1, 3, 6, 9 and 12 months)
    Primary objective is efficacy of compression intervention to change rate of progression from low volume swelling (LVS) (relative volume change (RVC) 5-\<10%) to breast cancer-related lymphedema (BCRL) (RVC \>/=10%). Measurement of effect of the compression intervention will be completed with arm volume measurements using perometry (infrared optical electronic scanner) .

Countries

United States

Locations and Investigators

  • Massachusetts General Hospital Cancer Center, Boston, United States
    • Alphonse G Taghian, MD PhD
    • Alphonse G Taghian, MD PhD (Principal Investigator)

Study Officials