Sensor-Embedded Compression Sleeve for Lymphedema

Recruiting in Palo Alto (17 mi)

Overseen byAlphonse G. Taghian, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

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

Eligibility Criteria

This trial is for women over 18 who've had breast cancer surgery with lymph node removal and are at high risk of developing arm swelling (lymphedema). They must understand English, be able to consent, and have slight swelling post-surgery. It's not for those with bilateral breast cancer, existing lymphedema treatment, metastases causing lymphedema, or pregnant women.

Inclusion Criteria

I am a woman over 18 who had breast cancer surgery with lymph node removal.

I have had swelling of 5-10% for more than 12 weeks after surgery.

I am at high risk of lymphedema because I had lymph nodes removed.

+1 more

Exclusion Criteria

I have been diagnosed or treated for lymphedema after breast cancer.

I have breast cancer in both breasts.

I have cancer spread that could lead to lymphedema in my arm.

+1 more

Participant Groups

The study tests a Juzo Compression Sleeve and Glove equipped with a sensor designed to prevent lymphedema in patients after breast cancer surgery. This pilot study aims to see if the smart sleeve can detect changes that might indicate early stages of swelling.

1Treatment groups

Experimental Treatment

Group I: Compression therapyExperimental Treatment2 Interventions

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.