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Trial Title:
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study
NCT ID:
NCT06305884
Condition:
Hematopoietic and Lymphoid System Neoplasm
Lymphedema
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Lymphedema
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Bioelectric Impedance Analysis
Description:
Undergo BI
Arm group label:
Diagnostic (BI, PPG)
Other name:
BIA
Other name:
Bioelectric Impedance
Other name:
Bioelectric Impedance Test
Other name:
Bioelectrical Impedance Analysis
Other name:
Bioimpedance Analysis
Intervention type:
Other
Intervention name:
Exercise
Description:
Pedal an exercise bike
Arm group label:
Diagnostic (BI, PPG)
Other name:
Exercise Type
Intervention type:
Procedure
Intervention name:
Photoplethysmography
Description:
Undergo PPG
Arm group label:
Diagnostic (BI, PPG)
Other name:
PPG
Intervention type:
Behavioral
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Diagnostic (BI, PPG)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. Describe a unique signature using a combination of photoplethysmography and
bioimpedance that distinguishes participants with lymphedema in comparison to
participants without lymphedema at rest.
SECONDARY OBJECTIVES:
I. In participants with lymphedema, describe a unique signature using a combination of
photoplethysmography and bioimpedance that distinguishes the affected arm in comparison
to the unaffected arm.
II. Tolerability of the transcutaneous sensors during the participant data collection
session.
III. Use a combination of photoplethysmography and bioimpedance to identify likely cut
points for lymphedema in participants with lymphedema.
OUTLINE:
Participants undergo BI and wear "watch-like" sensors and undergo PPG at rest and while
active (pedaling an exercise bike) on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with active malignancy or ongoing cancer therapy will be excluded, though
breast cancer patients currently on endocrine monotherapy will be included
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carlo M. Contreras, MD
Phone:
614-293-3465
Email:
Carlo.Contreras@osumc.edu
Investigator:
Last name:
Carlo M. Contreras, MD
Email:
Principal Investigator
Start date:
April 22, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06305884
http://cancer.osu.edu
