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Subclinical Lymphedema Treatment Study
NCT03292198 · View on ClinicalTrials.gov ↗
Study Summary
Primary Objective * To compare the effectiveness of 2 treatment protocols for patients with breast cancer-related subclinical lymphedema identified through bioimpedance spectroscopy, L-dex scores Secondary Objectives * To determine the necessary duration of intervention to reverse L-dex scores back to a normal range in patients with breast cancer-related subclinical lymphedema * To determine the time elapsed post-surgically to the development of subclinical lymphedema identified by bioimpedance spectroscopy, L-dex scores * To identify risk factors for the development of subclinical lymphedema in patients with breast cancer * To identify factors associated with the progression to clinical lymphedema following treatment of subclinical lymphedema as identified by bioimpedance spectroscopy, L-dex scores Women with breast cancer diagnoses and planned axillary lymph node procedures will receive pre-operative screening of arm volume with bioimpedance, which will capture baseline measurements. Then, subjects will undergo periodic screenings for the first 3 years following surgery. If a significant change in volume compared to baseline is detected with bioimpedance, subjects will be randomized to 1 of 2 treatment groups. The outcomes of 2 treatment protocols will be compared. Additionally, subjects will be screened each week during their treatment interventions to determine the necessary quantity of intervention before L-dex scores normalize.
Conditions Studied
Interventions
- OTHER 20-30 mmHg compression sleeve and gauntlet
- OTHER Manual Lymphatic Drainage
Study Locations (1)
Missouri
- Mercy David C. Pratt Cancer Center — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03292198
The ClinicalTrials.gov registry entry for NCT03292198 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercy Research, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer-related Subclinical Lymphedema appearing as the primary indexed condition, and to 2 interventions — of which 20-30 mmHg compression sleeve and gauntlet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03292198 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03292198 about?
NCT03292198 is a clinical study titled "Subclinical Lymphedema Treatment Study". Primary Objective * To compare the effectiveness of 2 treatment protocols for patients with breast cancer-related subclinical lymphedema identified through bioimpedance spectroscopy, L-dex scores Secondary Objectives * To determine the necessary duration of intervention to reverse L-dex scores ba...
What is the current status of trial NCT03292198?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 267 participants. The study started on 2018-04-01. Estimated completion is 2025-12.
What conditions does trial NCT03292198 study?
This clinical trial studies the following conditions: Breast Cancer-related Subclinical Lymphedema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03292198?
The interventions under investigation include: 20-30 mmHg compression sleeve and gauntlet (OTHER), Manual Lymphatic Drainage (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03292198?
This trial is sponsored by Mercy Research, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03292198 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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