Sensor-Embedded Compression Sleeve for Lymphedema

Overseen By Alphonse G Taghian, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Bilateral BC, Metastatic disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new compression sleeve and glove with sensors to determine if they can prevent lymphedema (swelling from fluid buildup) after breast cancer surgery. Participants will wear the compression gear daily for four weeks and record their experiences in a journal. Women who have undergone breast cancer surgery with lymph node removal and have experienced some swelling are ideal candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgery care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this sensor-embedded compression sleeve is safe for preventing lymphedema?

Research has shown that correct use of compression therapy rarely causes serious side effects. This includes the sensor-equipped compression sleeve tested in the current study. In a similar study, a wearable compression device proved safe for 40 participants.

Overall, wearing the sleeve as instructed is usually well-tolerated. Following the instructions is crucial to avoid any issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sensor-embedded compression sleeve for lymphedema because it offers a smart twist on traditional compression therapy. Unlike standard compression garments that only provide pressure, this innovative sleeve integrates sensors to track how well the sleeve is used and its effectiveness. This data-driven approach allows for personalized treatment adjustments and gives real-time feedback to both patients and healthcare providers. By providing a more interactive and tailored experience, this treatment could significantly enhance the quality of life for those managing lymphedema.

What evidence suggests that this compression sleeve sensor is effective for preventing lymphedema?

Research has shown that compression sleeves, such as the Sensor-Embedded Compression Sleeve in this trial, help reduce swelling in people with lymphedema and improve their quality of life. Early treatment with a compression sleeve can prevent the condition from worsening for at least six months. The sleeve gently squeezes the affected arm, helping to move fluid out of the swollen area. While this method is widely accepted, the sensors in this sleeve are designed to monitor pressure more accurately. This additional feature aims to enhance the precision and effectiveness of the treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Alphonse G. Taghian, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 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.

Participants who read and comprehend English, with the ability to understand and the willingness to sign a written consent document

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a compression sleeve with an embedded sensor to wear for 12 hours a day for four consecutive weeks

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 3, 6, 9, and 12 months

12 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Compression Sleeve Sensor
• Juzo Compression Sleeve and Glove

Trial Overview 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.

How Is the Trial Designed?

Group I: Compression therapy Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Olayan-Xefos Family Fund for Breast Cancer Research

Collaborator

Trials

1

Recruited

40+

Adele McKinnon Research Fund for Breast Cancer-Related Lymphedema

Collaborator

Trials

1

Recruited

40+

Heinz Family Foundation

Collaborator

Trials

3

Recruited

310+

Published Research Related to This Trial

The scoping review identified six studies that discussed various sensors for monitoring breast cancer-related lymphedema, highlighting a total of six different devices, both wearable and nonwearable.

Nonwearable sensors are currently more advanced and commercially available for remote lymphedema monitoring compared to wearable sensors, indicating a need for further development and validation in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Pressure Sensors to Help Support Community Lymphedema Monitoring: A Scoping Review. Rajab, O., Armstrong, E., Ferguson-Pell, M.[2023]

In a study of 48 breast cancer patients with lymphedema, adding padding to multilayer inelastic bandaging significantly increased both resting and working pressures, enhancing the effectiveness of compression therapy.

Patients who received additional padding experienced a greater reduction in limb volume after 2 weeks of treatment, indicating that padding can improve outcomes in lymphedema management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure monitoring of multilayer inelastic bandaging and the effect of padding in breast cancer-related lymphedema patients. Kang, Y., Jang, DH., Jeon, JY., et al.[2019]

A pilot study involving 40 subjects demonstrated that the Dayspring™ wearable compression system significantly improved quality of life (QoL) by 18% after 28 days of use, indicating its effectiveness in managing lymphedema.

The Dayspring device is user-friendly and allows for mobility during treatment, which may enhance adherence compared to traditional bulky pneumatic compression pumps, making it a promising alternative for lymphedema management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study. Rockson, SG., Karaca-Mandic, P., Skoracki, R., et al.[2022]

In a randomized controlled trial involving 20 women with lymphedema due to breast cancer treatment, combining compression therapy with active exercises significantly reduced arm size, indicating its efficacy in managing lymphedema.

The study showed a significant mean reduction in arm volume when exercises were performed with a compression sleeve (p-value < 0.007), highlighting the importance of compression in enhancing the effectiveness of physical activity for lymphedema management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. Godoy, Mde F., Pereira, MR., Oliani, AH., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-breast-cancer-lymphedema-9-2022-1c7db?lat=36.65114&lng=-97.3517

Sensor-Embedded Compression Sleeve for Lymphedema Research shows that compression therapy, like the Sensor-Embedded Compression Sleeve, can help reduce limb swelling and improve quality of life for lymphedema ...

2. researchgate.net researchgate.net/publication/370202621_Sensorizing_a_Compression_Sleeve_for_Continuous_Pressure_Monitoring_and_Lymphedema_Treatment_Using_Pneumatic_or_Resistive_Sensors

(PDF) Sensorizing a Compression Sleeve for Continuous ... Compression sleeves are the state of the art for treatment, but many open questions remain regarding effective pressure and usage prescriptions.

3. josephdelpreto.com josephdelpreto.com/wp-content/uploads/2023/04/DelPreto_smart-sleeve_RoboSoft2023.pdf

Sensorizing a Compression Sleeve for Continuous ... To help address these, this work presents a soft pressure sensor, a way to integrate it into wearable devices, and sensorized compression sleeves that.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7383414/

Risks and contraindications of medical compression treatment This consensus statement provides recommendations on medical compression therapy risks and contraindications.

5. mdpi.com mdpi.com/2072-6694/15/10/2674

Early Intervention with a Compression Sleeve in Mild ... It was shown that early treatment with a compression sleeve in compression class 1 in mild arm lymphedema can prevent progression for 6 months.

6. juzo.com juzo.com/en/products/compression-garments/donning-and-doffing-aids

Donning and doffing aids for compression garments Regular wearing of the garment contributes to a better treatment outcome and reduces physical effort on the part of the patient or nursing staff. For ...