Early Intervention

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05326165
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Alphonse G Taghian, MD, PhD
Phone	617-726-6050
Email	ataghian@mgh.harvard.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 2024
Completion date	June 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.