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Active, not recruiting Not applicable Interventional

Subclinical Lymphedema Treatment Study

ClinicalTrials.gov ID: NCT03292198

Public ClinicalTrials.gov record NCT03292198. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Treatment Indications for Breast Cancer-related Subclinical Lymphedema Identified Through a Bioimpedance Surveillance Model

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03292198
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Mercy Research
Other
Enrollment
267 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2018
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025
Last update posted
Oct 21, 2025

2018 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Mercy David C. Pratt Cancer Center St Louis Missouri 63141

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03292198, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 21, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03292198 live on ClinicalTrials.gov.

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