Clinical trial · Interventional
Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study
Project Limb Rescue: A Pilot Study Evaluating the Feasibility of Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioelectric Impedance Analysis | Procedure | — | UNRESOLVED |
| Exercise | Other | — | UNRESOLVED |
| Photoplethysmography | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (BI, PPG)
- description
- Participants undergo BIA and wear "watch-like" sensors and undergo PPG at rest and while active (pedaling an exercise bike) on study.
- interventionNames
- Procedure: Bioelectric Impedance Analysis
- Other: Exercise
- Procedure: Photoplethysmography
- Behavioral: Questionnaire Administration
Primary outcomes (1)
- measure
- Unique signature describing photoplethysmography and bioimpedance at rest and during activity
- timeFrame
- Up to 2 hours
- description
- 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).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available