Subclinical Lymphedema Treatment 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

• Breast Cancer-related Subclinical Lymphedema

Interventions

OTHER

20-30 mmHg compression sleeve and gauntlet

Compression garments are Juzo Soft, circular knit. Most will be off-the-shelf sizing, but custom when necessary. Garment fittings will be performed by Certified Lymphedema Therapists.

OTHER

Manual Lymphatic Drainage

Manual Lymphatic Drainage (MLD) is a gentle skin-stretch massage that stimulates the lymphatic system and assists in creating collateral drainage pathways out of non-intact (damaged) lymphatic territories. MLD is a critical part of Complete Decongestive Therapy (CDT), which is accepted as the international standard of care in the treatment of lymphedema. The MLD sessions will be performed by 2 Certified Lymphedema Therapists, Megan Klote and Sarah Stolker, both trained through the Norton School of Lymphatic Therapy. The therapists have completed reliability meetings regarding MLD sequencing and techniques.

Sponsors & Collaborators

• ImpediMed Limited

  collaborator INDUSTRY

• Mercy Research

  lead OTHER

Principal Investigators

• Megan T Klote, DPT, CLT-LANA · Mercy Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• United States

Study Locations