Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305884
• Other study ID #: OSU-21287
• Secondary ID: NCI-2023-03077
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Lymphedema
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Procedure:
• Bioelectric Impedance Analysis
Undergo BI

Other:
• Exercise
Pedal an exercise bike

Procedure:
• Photoplethysmography
Undergo PPG

Behavioral:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unique signature describing photoplethysmography and bioimpedance at rest and during activity	Will assess in the following groups: (1) Healthy dominant arm, (2) healthy recessive arm, (3) lymphedema normal arm and (4) lymphedema affected arm. A single continuous value will be developed from the amplitude over time for each participant, both at rest and during activity. These measurements will be summarized using descriptive statistics (means, standard deviations or medians and interquartile ranges).	Up to 2 hours
Secondary	Patient reported outcomes	Assess by the Lymph-Q questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables.	Up to 2 hours
Secondary	Tolerability of sensors	Assess by the Tolerability questionnaire. Will be summarized by cohort and compared between cohorts using the methods outlined above for continuous variables and either a Chi-square test or Fisher's Exact test for categorical variables.	Up to 2 hours
Secondary	Likely classification for lymphedema	Will examine receiver operator characteristics using data from groups 3 and 4. Sensitivity, specificity, and area under that curve will be calculated, however these will be considered preliminary.	Up to 2 hours

External Links

•   The Jamesline