Early Intervention

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Breast Cancer Treatment Related Lymphedema
• Intervention / Treatment: Device: Juzo Compression Sleeve and Glove; Device: Compression Sleeve Sensor

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alphonse G Taghian, MD, PhD; Phone Number: 617-726-6050; Email: ataghian@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center
      • Contact: Alphonse G Taghian, MD PhD; Phone Number: 617-726-6050; Email: ataghian@mgh.harvard.edu
      • Principal Investigator: Alphonse G Taghian, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible participants will be female, >/= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included.
• Eligible participants will demonstrate low volume swelling (RVC 5-<10%) >/=12 weeks postoperatively
• Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document.
• Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and/or regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC.

Exclusion Criteria:

• Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation.
• Participants will not be eligible if they have been diagnosed and/or treated for BCRL.
• Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded.
• Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Compression therapy; Participants 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arm Volume	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) .	1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor Accuracy	Accuracy will be defined as sensor-detected wear within ±4.17% of true wear	4 Weeks
Adherence rate to compression	Percentage of participants who wear the garment for >/=50% of the instructed time (>/=6 of 12 instructed hours per calendar day), >57% of calendar days (>/=4 days per week),	4 Weeks
Questionnaire Completion	Percentage of participants who complete Breast Cancer and Lymphedema Symptom Experience Index and Functional Assessment of Cancer Therapy-- Breast Cancer questionnaires at each study visit per study protocol.	1, 3, 6, 9 and 12 months

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Alphonse G Taghian, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast Cancer Treatment Related Lymphedema
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 21-600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes