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Clinical Trial NCT06305884 for Hematopoietic and Lymphoid System Neoplasm, Lymphedema, Malignant Solid Neoplasm is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study

Recruiting
Clinical Trial NCT06305884 is an interventional study for Hematopoietic and Lymphoid System Neoplasm, Lymphedema, Malignant Solid Neoplasm that is recruiting. It started on 22 April 2024 with plans to enroll 77 participants. Led by Ohio State University Comprehensive Cancer Center, it is expected to complete by 20 December 2025. The latest data from ClinicalTrials.gov was last updated on 29 June 2025.
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.
Detailed 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.

Official Title

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

Conditions
Hematopoietic and Lymphoid System NeoplasmLymphedemaMalignant Solid Neoplasm
Other Study IDs
NCT ID Number
NCT06305884
Start Date (Actual)
2024-04-22
Last Update Posted
2025-06-29
Completion Date (Estimated)
2025-12-20
Enrollment (Estimated)
77
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDiagnostic (BI, PPG)
Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
Bioelectric Impedance Analysis
Undergo BI
Exercise
Pedal an exercise bike
Photoplethysmography
Undergo PPG
Questionnaire Administration
Ancillary studies
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • Patients with active malignancy or ongoing cancer therapy will be excluded, though breast cancer patients currently on endocrine monotherapy will be included
Ohio State University Comprehensive Cancer Center logoOhio State University Comprehensive Cancer Center455 active trials to explore
Study Responsible Party
Carlo Contreras, Principal Investigator, Principal Investigator, Ohio State University Comprehensive Cancer Center
Study Central Contact
Contact: The Ohio State Comprehensive Cancer Center, 800-293-5066, [email protected]
Contact: Shannon Hainline, [email protected]
1 Study Locations in 1 Countries

Ohio

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Carlo M. Contreras, MD, Contact, 614-293-3465, [email protected]
Carlo M. Contreras, MD, Principal Investigator
Recruiting