Early Intervention

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05326165
• Other study ID #: 21-600
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: Alphonse G Taghian, MD, PhD
• Phone: 617-726-6050
• Email: ataghian[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Juzo Compression Sleeve and Glove
Elasticized garment sized for arm and hand to create pressure to reduce swelling
• Compression Sleeve Sensor
Small device embedded within compression sleeve garment collecting usage information

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema, Heinz Family Foundation, Olayan-Xefos Family Fund for Breast Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensor Accuracy	Accuracy will be defined as sensor-detected wear within ±4.17% of true wear	4 Weeks
Secondary	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
Secondary	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