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Adhesive-Based Sensors for Cancer-Related Lymphedema

N/A
Recruiting
Led By Carlo M Contreras, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing new adhesive-based sensors that stick to the skin to detect cancer-related long-term arm swelling. Lymphedema is a condition that causes swelling in the arms and can be painful and

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the interventions include non-invasive procedures like exercise, questionnaires, and sensor application for measurement purposes only, there are minimal expected side effects from participating in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Unique signature describing photoplethysmography and bioimpedance at rest and during activity
Secondary study objectives
Likely classification for lymphedema
Patient reported outcomes
Tolerability of sensors

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bioelectric Impedance Analysis
2012
Completed Phase 2
~120
Photoplethysmography
2021
Completed Phase 3
~480
Questionnaire Administration
2016
Completed Phase 3
~5020

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
294,425 Total Patients Enrolled
Carlo M Contreras, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
145 Total Patients Enrolled
~45 spots leftby Dec 2025
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