Adhesive-Based Sensors for Cancer-Related Lymphedema

Overseen By Shannon Hainline

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Active malignancy, Ongoing cancer therapy, others

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

Compensation: Varies

Number of Visits: 1

77 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new adhesive-based sensors that stick to the skin to evaluate their effectiveness in detecting lymphedema, a type of arm swelling that can occur after cancer treatment. Lymphedema can be painful and difficult to detect early, but early detection makes treatment easier. The sensors use light and small electrical currents to assess tissue response, potentially helping individuals monitor for lymphedema at home. The trial seeks healthy participants and those with arm swelling from previous cancer treatments like surgery or radiation. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve early detection and management of lymphedema.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on endocrine monotherapy for breast cancer, you can continue with it while participating in the trial.

What prior data suggests that these adhesive-based sensors are safe for detecting lymphedema?

Research has shown that adhesive-based sensors used to detect lymphedema are generally safe, though detailed safety information remains unavailable. These sensors adhere to the skin and employ photoplethysmography (PPG) and bioimpedance (BI). PPG checks changes in blood flow using light, while BI measures the body's response to a small electrical current. Although these methods are usually safe, the absence of detailed safety data suggests participants might experience mild skin irritation from the adhesives, a common issue with skin sensors.

Other studies have used these sensors to monitor lymphedema, and since they don't involve surgery or needles, they are generally easy to tolerate. However, without specific information on side effects, participants should report any discomfort to the study team. This trial tests a diagnostic tool, not a new drug, so the risks are likely lower than in typical drug trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about adhesive-based sensors for cancer-related lymphedema because they offer a non-invasive and continuous monitoring alternative to traditional methods like manual measurements and imaging. Unlike other treatments that rely on periodic check-ups, these transcutaneous sensors provide real-time data by simply being worn like a watch, allowing for ongoing tracking of lymphedema. Additionally, these sensors work both at rest and during physical activity, offering a more comprehensive picture of how lymphedema affects patients' daily lives. This innovative approach could lead to earlier detection and more personalized management of the condition.

What evidence suggests that these adhesive-based sensors are effective for detecting lymphedema?

Research has shown that small sensors adhering to the skin can effectively detect early signs of lymphedema, a type of arm swelling related to cancer. Participants in this trial will use these sensors, which employ light to detect changes in blood flow and measure how body tissues respond to a tiny electrical current. Early results suggest these sensors can identify lymphedema sooner than traditional methods, which often require hospital visits. Early detection is crucial because treatment is more successful when initiated promptly. This technology could enable patients to monitor their condition at home, potentially reducing the need for frequent hospital visits. ^{1 2 6 7 8}

Who Is on the Research Team?

Carlo M. Contreras, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with pre-existing lymphedema due to cancer therapy involving surgery or radiation. Participants should have arm swelling needing compression or a significant size difference between arms. Active cancer patients, except breast cancer ones on endocrine monotherapy, can't join.

Inclusion Criteria

I had cancer treatment with surgery or radiation targeting the armpit area.

COHORT A: Healthy participants

COHORT B: Participants with pre-existing lymphedema

Exclusion Criteria

I am not receiving cancer treatment, except for hormone therapy for breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diagnostic Assessment

Participants undergo bioimpedance analysis (BIA) and wear 'watch-like' sensors for photoplethysmography (PPG) at rest and while active

Up to 2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the sensor technology

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Sensors

Trial Overview The study tests new skin-adhesive sensors that detect early signs of lymphedema using photoplethysmography (PPG) and bioimpedance (BI). PPG measures blood volume changes in tissue, while BI assesses tissue response to electrical currents. The goal is to help patients monitor lymphedema at home.

How Is the Trial Designed?

Group I: Diagnostic (BI, PPG) Experimental Treatment 4 Interventions

Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

The Wet-Adaptive Electronic Skin (WADE-skin) is a new type of skin electronics that can adhere to wet skin and maintain its functionality even in moist environments, making it ideal for long-term health monitoring.

WADE-skin has been shown to effectively record electrocardiograms during sweating and underwater activities, demonstrating its potential for use in various real-world applications without harming skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wet-Adaptive Electronic Skin. Chen, F., Zhuang, Q., Ding, Y., et al.[2023]

The study involved 90 women (30 healthy, 30 with breast cancer before surgery, and 30 with established lymphedema) and used the tissue dielectric constant (TDC) method to measure local tissue water (LTW) in the forearms, showing that LTW in at-risk arms is not significantly affected by breast cancer.

A TDC arm ratio of 1.26 is proposed as a potential threshold for detecting early signs of lymphedema, indicating that this method could be useful for identifying patients at risk before clinical symptoms develop.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local tissue water in at-risk and contralateral forearms of women with and without breast cancer treatment-related lymphedema. Mayrovitz, HN., Weingrad, DN., Davey, S.[2009]

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]

Breast cancer-related lymphedema (BCRL) affects about 20% of breast cancer patients, and early diagnosis through comprehensive screening can prevent its progression and improve quality of life.

The Massachusetts General Hospital's prospective screening program utilizes advanced technologies like perometry and bioimpedance spectroscopy, along with clinical assessments, to accurately diagnose and monitor BCRL, highlighting the importance of both objective and subjective data in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of technology to facilitate a prospective surveillance program for breast cancer-related lymphedema at the Massachusetts General Hospital. Havens, LM., Brunelle, CL., Gillespie, TC., et al.[2021]

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]

The study introduces low-cost, single-use omniphobic paper-based smart bandages (OPSBs) that can wirelessly monitor chronic wound status by measuring pH and uric acid levels, making them a practical tool for managing chronic skin wounds.

These smart bandages, combined with a reusable wearable potentiostat, can detect early signs of pressure ulcer formation in an in-vivo mouse model, potentially allowing for timely intervention before visible tissue damage occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection and monitoring of chronic wounds using low-cost, omniphobic paper-based smart bandages. Pal, A., Goswami, D., Cuellar, HE., et al.[2019]

Bioelectrical spectroscopy (BIS) has been shown to provide highly reliable measurements for assessing limb fluid in patients with lymphedema, with inter-rater reliability at 0.987 and intrarater reliability at 0.993 based on a study involving 10 subjects.

BIS demonstrated strong concurrent validity when compared to the established perometry method, with a correlation of -0.904, indicating that it can be a valid alternative for evaluating lymphedema in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between bioelectrical spectroscopy and perometry in assessment of upper extremity swelling. Jain, MS., Danoff, JV., Paul, SM.[2023]

The wearable pendant sensor (WPS) developed for monitoring compliance with the optimal lymph flow (TOLF) exercise program shows a strong correlation with a standard motion capture system, indicating its potential effectiveness in tracking exercise performance for lymphedema prevention.

This IoT-based device could enable remote monitoring of patients' adherence to the TOLF therapy, potentially improving treatment outcomes and reducing the risk of developing lymphedema post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable Pendant Sensor to Monitor Compliance with Range of Motion Lymphatic Health Exercise. Wazir, HK., Reddy Bethi, S., Kumar, AR., et al.[2020]

The study introduces a non-invasive electronic sensor platform that can be applied near wounds to provide accurate, quantitative data on skin temperature and thermal conductivity, which is crucial for managing surgical wound healing.

Clinical trials demonstrated the effectiveness of this 'epidermal' electronics system in real-world settings, offering practical procedures for disinfection and reuse, potentially improving chronic wound management significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifunctional skin-like electronics for quantitative, clinical monitoring of cutaneous wound healing. Hattori, Y., Falgout, L., Lee, W., et al.[2021]

The ultrathin, stretchable hydration monitors with embedded impedance sensors can accurately measure skin hydration levels noninvasively, making them suitable for various applications in dermatology and health monitoring.

These devices demonstrate excellent precision and accuracy in measuring hydration across different skin depths, and their skin-like properties allow for comfortable integration with the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermal impedance sensing sheets for precision hydration assessment and spatial mapping. Huang, X., Cheng, H., Chen, K., et al.[2013]

A new portable prototype has been developed to continuously monitor the temperature of long-term wounds, which can help caregivers assess the wound's status over time.

The system uses flexible medical-grade materials and printed sensors to provide real-time data, enabling healthcare professionals to make informed decisions about wound treatment and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible Hybrid Electrodes for Continuous Measurement of the Local Temperature in Long-Term Wounds. Rodes-Carbonell, AM., Torregrosa-Valls, J., Guill Ibáñez, A., et al.[2021]

A consensus was reached among 70 experts on a core dataset for monitoring upper limb lymphoedema, which aims to standardize the assessment and reporting of this condition.

The finalized dataset includes key metrics like interlimb difference as a percentage and limb volume, which will help create a clinical support system for better management of lymphoedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attaining consensus on a core dataset for upper limb lymphoedema using the Delphi method: A foundational step in creating a clinical support system. Sierla, R., Dylke, E., Poon, S., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03077

Transcutaneous Sensors for the Detection of ... This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm ...

2. withpower.com withpower.com/trial/phase-lymphedema-3-2024-4000f

Adhesive-Based Sensors for Cancer-Related Lymphedema This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06778837

Study Details | NCT06778837 | Lymphedema Sensor ... The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors ...

4. health.osu.edu health.osu.edu/health/cancer/using-smartwatches-to-detect-lymphedema

Using smartwatches to detect lymphedema | Ohio State Health ... Adhesive-based sensors will gather real-time data on changes in tissue, using custom Android-based smartwatch software that Ohio State ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05326165

Study Details | NCT05326165 | Early Intervention This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema. Detailed Description. This is a ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/467895

Transcutaneous Sensors for the Detection of Cancer ... This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related ...

7. bmj.com bmj.com/content/390/bmj-2024-081351.full.pdf

Cancer related lymphedema These data confirm the effectiveness of liposuction when patients closely adhere to post-treatment compression therapy. Functional lymphatic ...

8. studysearch.osumc.edu studysearch.osumc.edu/taxonomy/term/30

Cancer | StudySearch The goal of this study is to use new, adhesive-based sensors (pads that stick on your skin) to detect lymphedema, and to develop a way for patients to check for ...