Breast CancerNCT05326165
Early Intervention
A study testing Juzo Compression Sleeve and Glove and Compression Sleeve Sensor in people with Breast Cancer and Breast Cancer Treatment Related Lymphedema, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Treatment Related Lymphedema
- What is being tested?
- Juzo Compression Sleeve and Glove and Compression Sleeve Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Alphonse G Taghian, MD PhD, 617-726-6050, ataghian@mgh.harvard.edu
Alphonse G Taghian, MD PhD
About this study
Official title: 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.
Read the 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:
- a compression garment worn for four weeks helps to prevent breast cancer-related lymphedema (BCRL) in those at high risk of BCRL
- a sensor attached to the sleeve is accurately measuring time worn and pressure applied
- participants are wearing the compression for the prescribed time, and if not, what are the barriers to wear
- 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.
- Being tested
- Juzo Compression Sleeve and Glove, Compression Sleeve Sensor
- Keywords
- Breast Cancer, Breast Cancer Treatment Related Lymphedema
- Medical subject headings
- Breast Neoplasms, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juzo Compression Sleeve and GloveDevice
Elasticized garment sized for arm and hand to create pressure to reduce swelling
Compression Sleeve SensorDevice
Small device embedded within compression sleeve garment collecting usage information
| Study group | Role | What they receive |
|---|---|---|
| Compression therapy | Experimental | 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. Receives: Device: Juzo Compression Sleeve and Glove; Device: Compression Sleeve Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 1, 3, 6, 9 and 12 months
Secondary outcomes (3)
Sensor Accuracy
Accuracy will be defined as sensor-detected wear within ±4.17% of true wear
Measured: 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),
Measured: 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.
Measured: 1, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study startMay 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heinz Family Foundation, Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema, Olayan-Xefos Family Fund for Breast Cancer Research
- Responsible party
- Principal investigator, Alphonse Taghian, Massachusetts General Hospital
- Investigators
- Alphonse G Taghian, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326165
- Sponsor's protocol ID
- 21-600
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.