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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.

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 data supports the effectiveness of adhesive-based sensors for detecting cancer-related lymphedema?

The research highlights the importance of technology in monitoring lymphedema, with nonwearable sensors being more developed for remote monitoring. Additionally, bioelectrical spectroscopy (BIS) has shown high reliability and validity in assessing limb fluid, suggesting that similar sensor technologies could be effective for lymphedema detection. ^{1 2 3 4 5}

Is it safe to use adhesive-based sensors for monitoring lymphedema?

The research does not provide specific safety data for adhesive-based sensors, but it discusses the use of various technologies for monitoring lymphedema, suggesting that these technologies are generally considered safe for use in humans. ^{1 2 5 6 7}

How does the adhesive-based sensor treatment for cancer-related lymphedema differ from other treatments?

The adhesive-based sensor treatment for cancer-related lymphedema is unique because it uses wearable sensors to non-invasively monitor the condition, providing real-time data on skin hydration and other physiological signals. This approach is different from traditional treatments that may not offer continuous monitoring or the ability to adapt to wet skin conditions. ^{8 9 10 11 12}

Research Team

Carlo M. Contreras, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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 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 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]

References

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

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

2. China pubmed.ncbi.nlm.nih.gov

Use of technology to facilitate a prospective surveillance program for breast cancer-related lymphedema at the Massachusetts General Hospital. [2021]

3. 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]

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

A Wearable Pendant Sensor to Monitor Compliance with Range of Motion Lymphatic Health Exercise. [2020]

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

Correlation between bioelectrical spectroscopy and perometry in assessment of upper extremity swelling. [2023]

6. Australia 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. [2023]

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

Local tissue water in at-risk and contralateral forearms of women with and without breast cancer treatment-related lymphedema. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Early detection and monitoring of chronic wounds using low-cost, omniphobic paper-based smart bandages. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Multifunctional skin-like electronics for quantitative, clinical monitoring of cutaneous wound healing. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Wet-Adaptive Electronic Skin. [2023]

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

Epidermal impedance sensing sheets for precision hydration assessment and spatial mapping. [2013]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Flexible Hybrid Electrodes for Continuous Measurement of the Local Temperature in Long-Term Wounds. [2021]