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

NCT06305884 | Completed DMC

• 2 other identifiers: OSU-21287NCI-2023-03077
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Lymphedema; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient reported outcomes

  Up to 2 hours

• Tolerability of sensors

  Up to 2 hours

• Likely classification for lymphedema

  Up to 2 hours

Study Arms (1)

Diagnostic (BI, PPG)

EXPERIMENTAL

Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.

Procedure: Bioelectric Impedance Analysis; Other: Exercise; Procedure: Photoplethysmography; Behavioral: Questionnaire Administration

Interventions

Exercise OTHER

Pedal an exercise bike

Also known as: Exercise Type

Diagnostic (BI, PPG)

Bioelectric Impedance Analysis PROCEDURE

Undergo BI

Also known as: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis

Diagnostic (BI, PPG)

Photoplethysmography PROCEDURE

Undergo PPG

Also known as: PPG

Diagnostic (BI, PPG)

Questionnaire Administration BEHAVIORAL

Ancillary studies

Diagnostic (BI, PPG)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Lymphedema

Interventions

Exercise; Exercise Therapy

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Carlo M Contreras, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 22, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)