Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema,

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hematopoietic and Lymphoid System Neoplasm
Lymphedema
Malignant Solid Neoplasm
Neoplasms

Clinical Trial Details

NCT number	NCT06305884
Study type	Interventional
Source	Ohio State University Comprehensive Cancer Center
Contact	The Ohio State Comprehensive Cancer Center
Phone	800-293-5066
Email	OSUCCCClinicaltrials@osumc.edu
Status	Recruiting
Phase	N/A
Start date	April 22, 2024
Completion date	December 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05507346` - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema	N/A
Completed	`NCT06067880` - Surgical Intervention and Lymphatic Diseases.
Active, not recruiting	`NCT04797390` - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema	N/A
Completed	`NCT02676752` - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed	`NCT06323200` - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
Completed	`NCT02506530` - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema	N/A
Completed	`NCT02253186` - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema	N/A
Terminated	`NCT02020837` - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema	Early Phase 1
Recruiting	`NCT01318785` - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications	Phase 2
Enrolling by invitation	`NCT02375165` - Biomarkers for the Detection of Lymphatic Insufficiency
Completed	`NCT00852930` - Low Level Laser Treatment and Breast Cancer Related Lymphedema	Phase 4
Completed	`NCT01112189` - Use of Stem Cells in Lymphedema Post Mastectomy	Phase 1/Phase 2
Completed	`NCT02308488` - Study of Prone Accelerated Breast And Nodal IMRT	N/A
Completed	`NCT00743314` - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer	Early Phase 1
Recruiting	`NCT06237907` - Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Terminated	`NCT01580800` - National Breast Cancer and Lymphedema Registry
Suspended	`NCT05366699` - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy	N/A
Completed	`NCT06249360` - Lymphatic System Reflux After Lymphatic Operation
Completed	`NCT06220903` - The Effect of Complex Decongestive Therapy in Patients With Lymphedema	N/A
Terminated	`NCT02923037` - Hatha Yoga in Breast Cancer Survivors	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms