NCT03648983

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

A Pilot Randomized Trial Comparing Arm Circumference and Bioimpedance Measurement for Early Detection and Treatment of Lymphedema in Patients Undergoing Axillary Lymph Node Dissection or Sentinel Node Biopsy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To test, in a randomized controlled trial, the ability of the enhanced lymphedema (LE) detection program (ELED) versus arm circumference alone to detect early/reversible LE. II. To compare the severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, between the two detection modalities. III. To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement/bioimpedance spectroscopy (BIS) difference. IV. To compare the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment between the enhanced vs. standard detection groups. V. To determine compliance with LE preventive care and treatment. Patients are randomized to 1 of 2 arms: those undergo arm circumference measurement only and those undergoing undergo arm circumference measurement and bioimpedance spectroscopy. Measurements taken at 4, 10, 16, 22, 28, and 34 months. In both arms, if lymphedema is diagnosed, patients are given a compression garment to wear daily for 6 weeks. If lymphedema does not improve after 6 weeks, patients undergo complete decongestive therapy over approximately 1 hour three times a week. Patients complete remedial exercises comprising active, repetitive range of motion of the involved extremity and light aerobic conditioning until extremity volume stabilizes or improves. Patients are also instructed to perform exercises at home. After completion of study, patients diagnosed with lymphedema are followed up for 1 year.

Conditions

• Lymphedema
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	arm circumference measurement	Undergo arm circumference measurement
DEVICE	Bioimpedance spectroscopy	bioimpedance spectroscopy

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2018-08-28
• Last updated: 2018-10-01
• Results posted: 2018-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study