Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• COHORT A: Healthy participants

• COHORT B: Participants with pre-existing lymphedema

• COHORT B: A history of cancer therapy with surgery or radiation involving the axillary basin

• COHORT B: Unilateral upper extremity swelling that requires compression or pneumatic therapy or a \>= 2-centimeter difference in contralateral arm circumference

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Backup
Shannon Hainline
Shannon.Hainline@osumc.edu
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 77
Treatments
Experimental: Diagnostic (BI, PPG)
Participants undergo BIA and wear watch-like sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov