Back to search results

Early Intervention for Breast Cancer-Related Lymphedema

This study is looking at whether wearing a Juzo Compression Sleeve and Glove can help prevent lymphedema (swelling) in your arm after breast cancer surgery. Lymphedema can happen when lymph nodes are removed during surgery. The compression sleeve has a special sensor to track how long you wear it and the pressure it applies. Researchers want to see if wearing this sleeve for four weeks helps prevent swelling, if the sensor works well, and why some people might not wear it as prescribed. This study is for women aged 18 or older who have had breast cancer surgery involving lymph node removal. Success in this study will be measured by changes in arm volume over 12 months. The current status of this study is unclear.

Study design
This is a pilot study with 40 participants, testing a compression sleeve intervention without a comparison group.
What's involved
You would undergo screening, receive the intervention, and attend follow-up visits, including filling out surveys.
Compensation
Not stated in the trial record.
Follow-up
Your arm volume will be measured at 1, 3, 6, 9, and 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05326165

Early Intervention

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
Massachusetts General Hospital
~40 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Juzo Compression Sleeve and GloveCompression Sleeve Sensor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arm Volume
Measured over 1, 3, 6, 9 and 12 months

Conditions

Breast Cancer
Breast Cancer Treatment Related Lymphedema

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Alphonse G Taghian, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Alphonse G Taghian, MD, PhD
[email protected]
617-726-6050
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Arm Volume1, 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) .