Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03292198 · ClinicalTrials.gov registry record · NA
Subclinical Lymphedema Treatment Study
A NA study of Breast Cancer-related Subclinical Lymphedema, sponsored by Mercy Research.
- Active
- Registry status
- NA
- Development phase
- 267
- Enrollment target
- 1
- Study location
NCT03292198 is a NA study of Breast Cancer-related Subclinical Lymphedema that is active but no longer recruiting, run by Mercy Research. The registered enrollment target is 267 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03292198, a NA study of Breast Cancer-related Subclinical Lymphedema, is active but no longer recruiting, sponsored by Mercy Research.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 267 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. 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 14 total studies on file at ClinicalTrials.gov.
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.
NCT03292198 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
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.
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).
Who is sponsoring clinical trial NCT03292198?
This trial is sponsored by Mercy Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.