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

The Ohio State University

Status: Active, not recruiting

Conditions: Lymphedema; Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06305884

NCI-2023-03077 (Registry Identifier)

OSU-21287

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Diagnostic (BI, PPG)

Experimental group

Description:

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

Treatment:

Procedure: Photoplethysmography

Other: Exercise

Behavioral: Questionnaire Administration

Procedure: Bioelectric Impedance Analysis