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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: Active NA study of Breast Cancer-related Subclinical Lymphedema, sponsored by Mercy Research.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT03292198 still lists
NCT03292198 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT03292198's enrollment target sits among peer trials
267 395th of 2000 higher than 1,606 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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