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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the Sensor-Embedded Compression Sleeve for Lymphedema treatment?

Research shows that compression therapy, like the Sensor-Embedded Compression Sleeve, can help reduce limb swelling and improve quality of life for lymphedema patients. A study on a similar wearable compression device found significant improvements in quality of life and limb volume, suggesting that such treatments are effective and easy to use. ^{1 2 3 4 5}

Is the Sensor-Embedded Compression Sleeve for Lymphedema safe for humans?

The Dayspring wearable compression device, similar to the Sensor-Embedded Compression Sleeve, was found to be safe in a study with 40 participants, showing improvements in quality of life and limb volume without reported safety issues. ^{1 2 4 6 7}

How does the Sensor-Embedded Compression Sleeve for Lymphedema differ from other treatments?

The Sensor-Embedded Compression Sleeve for Lymphedema is unique because it integrates sensors to monitor pressure and provides a customizable, graduated compression therapy that is both portable and economical, unlike traditional bulky pneumatic compression devices that require immobility during use. ^{2 4 8 9 10}

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.

Research Team

Alphonse G. Taghian, MD

Principal Investigator

Massachusetts General Hospital

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 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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Biotechnologies toward Mitigating, Curing, and Ultimately Preventing Edema through Compression Therapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, an Open-Label Controlled Study. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Synergic effect of compression therapy and controlled active exercises using a facilitating device in the treatment of arm lymphedema. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pressure monitoring of multilayer inelastic bandaging and the effect of padding in breast cancer-related lymphedema patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Exercising and Compression Mechanism in the Treatment of Lymphedema. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Home volumetry foretells a new era of self-management for patients with lymphedema after breast cancer. [2008]

7. Italy pubmed.ncbi.nlm.nih.gov

Lymphedema treatment by means of an electro-medical device based on bioresonance and vacuum technology: clinical and lymphoscintigraphic assessment. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

A Soft Robotic Sleeve for Compression Therapy of the Lower Limb. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Development of Pressure Sensors to Help Support Community Lymphedema Monitoring: A Scoping Review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A novel air microfluidics-enabled soft robotic sleeve: Toward realizing innovative lymphedema treatment. [2023]