Adhesive-Based Sensors for Cancer-Related Lymphedema
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University Comprehensive Cancer Center
Disqualifiers: Active malignancy, Ongoing cancer therapy, others
No Placebo Group
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.
12345Is 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.
12567How 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.
89101112Eligibility 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
+1 more
Exclusion Criteria
I am not receiving cancer treatment, except for hormone therapy for breast cancer.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (BI, PPG)Experimental Treatment4 Interventions
Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio State University Comprehensive Cancer CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
References
Development of Pressure Sensors to Help Support Community Lymphedema Monitoring: A Scoping Review. [2023]Breast cancer-related lymphedema is a condition occurring after a partial or full mastectomy, where there is a buildup of interstitial fluid in the body, particularly in the upper limb. There is a lack of at-home sensors that can help monitor the progression of lymphedema. The purpose of this scoping review is to gather relevant information on sensors for remote lymphedema monitoring. A literature search of Medline, PubMed, Scopus, Web of Science, and BMC databases yielded 96 studies. A total of six studies were selected for data extraction. Data were extracted from each study and organized into tables for analysis. A total of six different devices were mentioned in the six studies included in the scoping review, divided into wearable and nonwearable sensors. Nonwearable sensors were more likely to be adaptable for remote sensing as they were further along in development and commercially available on the market. Nonwearable sensors are more developed than wearable sensors for the purpose of remote lymphedema monitoring. This review advocates further development and validation of sensors for lymphedema management, particularly for remote monitoring and health assessments.
Use of technology to facilitate a prospective surveillance program for breast cancer-related lymphedema at the Massachusetts General Hospital. [2021]Breast cancer-related lymphedema (BCRL) is a negative sequela of breast cancer (BC) caused by trauma to the lymphatic system during surgery or radiation to the axillary lymph nodes. BCRL affects approximately one in five patients treated for BC, and patients are at a lifelong risk for BCRL after treatment. Early diagnosis of BCRL may prevent its progression and reduce negative effects on quality of life, necessitating comprehensive prospective screening. This paper provides an overview of technology that may be used as part of a BCRL screening program, including objective measures such as perometry, bioimpedance spectroscopy, tissue tonometry, and three-dimensional optical imaging. Furthermore, this paper comprehensively reviews the technology incorporated into the established prospective screening program at Massachusetts General Hospital. Our prospective screening program consists of longitudinal measurements via perometry, symptoms assessment, and clinical examination by a certified lymphedema therapist (CLT) as needed. Discussion about use of perometry within the screening program and incorporation of arm volume measurements into equations to determine change over time and accurate diagnosis is included [relative volume change (RVC) and weight-adjusted change (WAC) equations]. Use of technology throughout the program is discussed, including a HIPPA-compliant online research database, the patient's electronic medical record, and incorporation of BCRL-related symptoms [BC and lymphedema symptom experience index (BCLE-SEI) survey]. Ultimately, both subjective and objective data are used to inform BCRL diagnosis and treatment by the CLT. In conclusion, the role of technology in facilitating BCRL screening is indispensable, and the continued development of objective assessment methods that are not only reliable and valid, but also cost-effective and portable will help establish BCRL screening as the standard of care for patients treated for BC.
Pressure monitoring of multilayer inelastic bandaging and the effect of padding in breast cancer-related lymphedema patients. [2019]This study of pressure monitoring of multilayer inelastic bandaging and the effect of padding in breast cancer-related lymphedema patients aimed to measure the resting and working sub-bandage pressures in compression therapy for lymphedema patients and to determine whether applying additional padding has an additional effect in volume reduction of the limb.
A Wearable Pendant Sensor to Monitor Compliance with Range of Motion Lymphatic Health Exercise. [2020]Lymphedema is a chronic and debilitating condition affecting 1 in 1000 Americans and there is no known cure for it. The optimal lymph flow (TOLF) is an effective preventive exercise program designed to reduce the risks of lymphedema. This paper proposes a portable and wearable medical device to monitor compliance with the TOLF therapy. Specifically, the wearable pendant sensor (WPS), a low-fidelity prototype of the proposed design, is developed and tested in comparison with a markerless optical motion capture system (Kinect) for measurement accuracy during shoulder abduction-adduction and flexion-extension exercises. It is shown that the Kendall's Tau between the measurements obtained from the WPS and Kinect devices yields a correlation coefficient ρ = 0.807 for abduction-adduction exercise and ρ = 0.783 for flexion-extension exercise with a significance level of p
Correlation between bioelectrical spectroscopy and perometry in assessment of upper extremity swelling. [2023]Lymphedema is a common side effect of breast cancer treatment and is associated with increased upper extremity volume, functional impairment, and pain. While there is no cure for lymphedema, physical therapy treatment can often alleviate symptoms. To measure the efficacy of treatment, accurate assessment of the limbs is important. Current methods of assessment are complex (water displacement), marginally accurate (circumferential measurements), or expensive (opto-electrical systems). A new method for estimating tissue fluid is bioelectrical spectroscopy (BIS). This method measures impedance to small currents applied to the body and is easily performed. Acceptance of BIS devices for assessment of limb fluid will be dependent on the establishment of sufficient reliability and validity, and the objective of this study was to evaluate reliability and validity of this device compared to perometry. Both upper limbs of ten subjects previously treated for breast cancer were measured using BIS and perometry. We found that inter-rater reliability (r = 0.987) and intrarater reliability (r = 0.993) were acceptably high for the BIS unit and concurrent validity was r = -0.904, when compared to perometry. These results confirm that BIS can produce valid and reliable data related to the assessment of upper limbs affected by lymphedema.
Attaining consensus on a core dataset for upper limb lymphoedema using the Delphi method: A foundational step in creating a clinical support system. [2023]Background: Lymphoedema is a condition of localised swelling caused by a compromised lymphatic system. The protein-rich fluid accumulating in the interstitial tissue can create inflammation and irreversible changes to the skin and underlying tissue. An array of methods has been used to assess and report these changes. Heterogeneity is evident in the clinic and in the literature for the domains assessed, outcomes and outcome measures selected, measurement protocols followed, methods of analysis, and descriptors used to report change. Objective: This study seeks consensus on the required items for inclusion in a core data set for upper limb lymphoedema to digitise the monitoring and reporting of upper limb lymphoedema. Methods: The breadth of outcomes and descriptors in common use were captured in prior studies by this research group. This list was refined by frequency and proposed to experts in the field (n = 70) through a two-round online modified Delphi study. These participants rated the importance of each item for inclusion in the dataset and identified outcomes or descriptors they felt were missing in Round 1. In Round 2, participants rated any new outcomes or descriptors proposed and preference for how numeric data is displayed. Results: The core dataset was confirmed on completion of Round 2. Interlimb difference as a percentage, and limb volume were preferred for graphed display over time; and descriptors for observed and palpated change narrowed from 42 to 20. Conclusion: This dataset provides the foundation to create a clinical support system for upper limb lymphoedema.
Local tissue water in at-risk and contralateral forearms of women with and without breast cancer treatment-related lymphedema. [2009]Quantitative measurements to help detect incipient or latent lymphedema in patients at risk for breast cancer treatment-related lymphedema (BCRL) are potentially useful supplements to clinical assessments. Suitable measurements for routine use include arm volumes, arm bioimpedance, and local tissue water (LTW) determined from the tissue dielectric constant (TDC). Because BCRL initially develops in skin and subcutis, measures that include whole arms may not be optimally sensitive for detecting the earliest changes. Thus, there is also a need for a local measurement in which tissues most likely to demonstrate early lymphedematous changes can be more selectively assessed. The TDC method satisfies this criterion. Our goal was to use this method to compare arm-to-arm differences in LTW within and among women grouped as healthy normal (HN), diagnosed with breast cancer (BC), but prior to surgery and established unilateral lymphedema (LE).
Early detection and monitoring of chronic wounds using low-cost, omniphobic paper-based smart bandages. [2019]The growing socio-economic burden of chronic skin wounds requires the development of new automated and non-invasive analytical systems capable of wirelessly monitoring wound status. This work describes the low-cost fabrication of single-use, omniphobic paper-based smart bandages (OPSBs) designed to monitor the status of open chronic wounds and to detect the formation of pressure ulcers. OPSBs are lightweight, flexible, breathable, easy to apply, and disposable by burning. A reusable wearable potentiostat was fabricated to interface with the OPSB simply by attaching it to the back of the bandage. The wearable potentiostat and the OPSB can be used to simultaneously quantify pH and uric acid levels at the wound site, and wirelessly report wound status to the user or medical personnel. Additionally, the wearable potentiostat and the OPSBs can be used to detect, in an in-vivo mouse model, the formation of pressure ulcers even before the pressure-induced tissue damage becomes visible, using impedance spectroscopy. Our results demonstrate the feasibility of using inexpensive single-use OPSBs and a reusable, wearable potentiostat that can be easily sterilized and attached to a new OPSB during the dressing change, to provide long term wound progression data to guide treatment decisions.
Multifunctional skin-like electronics for quantitative, clinical monitoring of cutaneous wound healing. [2021]Non-invasive, biomedical devices have the potential to provide important, quantitative data for the assessment of skin diseases and wound healing. Traditional methods either rely on qualitative visual and tactile judgments of a professional and/or data obtained using instrumentation with forms that do not readily allow intimate integration with sensitive skin near a wound site. Here, an electronic sensor platform that can softly and reversibly laminate perilesionally at wounds to provide highly accurate, quantitative data of relevance to the management of surgical wound healing is reported. Clinical studies on patients using thermal sensors and actuators in fractal layouts provide precise time-dependent mapping of temperature and thermal conductivity of the skin near the wounds. Analytical and simulation results establish the fundamentals of the sensing modalities, the mechanics of the system, and strategies for optimized design. The use of this type of "epidermal" electronics system in a realistic clinical setting with human subjects establishes a set of practical procedures in disinfection, reuse, and protocols for quantitative measurement. The results have the potential to address important unmet needs in chronic wound management.
Wet-Adaptive Electronic Skin. [2023]Skin electronics provides remarkable opportunities for non-invasive and long-term monitoring of a wide variety of biophysical and physiological signals that are closely related to health, medicine, and human-machine interactions. Nevertheless, conventional skin electronics fabricated on elastic thin films are difficult to adapt to the wet microenvironments of the skin: Elastic thin films are non-permeable, which block the skin perspiration; Elastic thin films are difficult to adhere to wet skin; Most skin electronics are difficult to work underwater. Here, a Wet-Adaptive Electronic Skin (WADE-skin) is reported, which consists of a next-to-skin wet-adhesive fibrous layer, a next-to-air waterproof fibrous layer, and a stretchable and permeable liquid metal electrode layer. While the electronic functionality is determined by the electrode design, this WADE-skin simultaneously offers superb stretchability, wet adhesion, permeability, biocompatibility, and waterproof property. The WADE-skin can rapidly adhere to human skin after contact for a few seconds and stably maintain the adhesion over weeks even under wet conditions, without showing any negative effect to the skin health. The use of WADE-skin is demonstrated for the stable recording of electrocardiogram during intensive sweating as well as underwater activities, and as the strain sensor for the underwater operation of virtual reality-mediated human-machine interactions.
Epidermal impedance sensing sheets for precision hydration assessment and spatial mapping. [2013]This paper presents a class of hydration monitor that uses ultrathin, stretchable sheets with arrays of embedded impedance sensors for precise measurement and spatially multiplexed mapping. The devices contain miniaturized capacitive electrodes arranged in a matrix format, capable of integration with skin in a conformal, intimate manner due to the overall skin-like physical properties. These "epidermal" systems noninvasively quantify regional variations in skin hydration, at uniform or variable skin depths. Experimental results demonstrate that the devices possess excellent uniformity, with favorable precision and accuracy. Theoretical models capture the underlying physics of the measurement and enable quantitative interpretation of the experimental results. These devices are appealing for applications ranging from skin care and dermatology, to cosmetology and health/wellness monitoring, with the additional potential for combined use with other classes of sensors for comprehensive, quantitative physiological assessment via the skin.
Flexible Hybrid Electrodes for Continuous Measurement of the Local Temperature in Long-Term Wounds. [2021]Long-term wounds need a continuous assessment of different biophysical parameters for their treatment, and there is a lack of affordable biocompatible devices capable of obtaining that uninterrupted flow of data. A portable prototype that allows caregivers to know the local temperature behavior of a long-term wound over time and compare it with different reference zones has been developed. Alternative flexible substrates, screen-printing techniques, polymeric inks, and an embedded system have been tested to achieve potential indicators of the status and evolution of chronic wounds. The final system is formed by temperature sensors attached to a flexible and stretchable medical-grade substrate, where silver conductive tracks have been printed as interconnections with the data-acquisition unit. In addition, a specific datalogger has been developed for this system. The whole set will enable health personnel to acquire the temperature of the wound and its surroundings in order to make decisions regarding the state and evolution of the wound.