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Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer

NCT03648983 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-10-01

Study results available
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Summary

This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Diagnostic procedures, such as bioimpedance spectroscopy, may allow doctors to find and diagnose lymphedema earlier than arm circumference measurement alone.

Conditions

Interventions

PROCEDURE

arm circumference measurement

Undergo arm circumference measurement

DEVICE

Bioimpedance spectroscopy

bioimpedance spectroscopy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Lisa Wiechmann · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-08-31
Completion
2015-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648983 on ClinicalTrials.gov