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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2026-02-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematopoietic and Lymphoid System Neoplasm Lymphedema Malignant Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bioelectric Impedance Analysis

Intervention Type PROCEDURE

Undergo BI

Exercise

Intervention Type OTHER

Pedal an exercise bike

Photoplethysmography

Intervention Type PROCEDURE

Undergo PPG

Questionnaire Administration

Intervention Type BEHAVIORAL

Ancillary studies

Interventions

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Bioelectric Impedance Analysis

Undergo BI

Intervention Type PROCEDURE

Exercise

Pedal an exercise bike

Intervention Type OTHER

Photoplethysmography

Undergo PPG

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type BEHAVIORAL

Other Intervention Names

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BIA Bioelectric Impedance Bioelectric Impedance Test Bioelectrical Impedance Analysis Bioimpedance Analysis Exercise Type PPG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes