Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subclinical Lymphedema Treatment Study (SLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03292198
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Mercy Foundation
St. Louis Men's Group Against Cancer
ImpediMed Limited
Juzo USA
Information provided by (Responsible Party):
Megan Klote, Mercy Research

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer-related Subclinical Lymphedema Other: 20-30 mmHg compression sleeve and gauntlet Other: Manual Lymphatic Drainage Not Applicable

Detailed Description:

Lymphedema is an accumulation of fluid in the interstitial tissues resulting from an impairment of the normal lymphatic drainage of the affected region. Lymphedema is often a side effect of breast cancer treatments such as axillary lymph node surgery and radiation, as these procedures are damaging to the lymphatic structures. Due to poor awareness of the condition, minimal education is given to patients about their risk for lymphedema as a result of cancer treatments. With inconsistent diagnostic methods, many cases of breast cancer-related lymphedema are diagnosed after the condition has progressed to its irreversible and chronic form, i.e. clinical lymphedema.

Bioimpedance spectroscopy (BIS) uses a low frequency electrical current to assess extracellular fluid of the limbs. BIS has proven to be a sensitive and specific tool for detecting subclinical lymphedema (Stage 0) and has been validated in its use within a surveillance model. Recent literature supports the use of a surveillance model to identify breast cancer-related subclinical lymphedema to allow for early intervention and improved patient outcomes.

Despite the growing body of evidence supporting the importance of early identification of lymphedema in the subclinical stage, there is limited evidence to guide treatment of this patient population. Treatment parameters for subclinical lymphedema stem primarily from a study by Stout et al. indicating that a short compression trial (mean duration of 4.4 weeks) of 20-30 mmHg garments effectively treated subclinical lymphedema identified by perometry by preventing progression to late-stage lymphedema.

Surveillance of arm volume will be performed using bioimpedance spectroscopy (BIS) testing with the Impedimed® L-dex U400. Subjects will receive BIS testing (1) pre-operatively, (2) post-operatively at 6 weeks, (3) 3 months, (4) 6 months, (5) 12 months, (6) 18 months, (7) 24 months, and (8) 36 months. The outcome measure will be the L-dex score.

Only subjects who have an abnormal result will be enrolled in the experimental portion of the study. If an L-dex score is abnormal (defined by a change of +7 units from her pre-operative baseline), the subject is determined to exhibit subclinical lymphedema. As a result, these subjects will be randomized into one of two intervention groups. The group receiving only compression intervention will be referred to as the compression group (CG). The group receiving Manual Lymphatic Drainage (MLD) and compression will be referred to as the therapy group (TG).

Subjects will be followed through screenings for a maximum of 3 years post-surgically.

The investigators hope that this study will take the next step in the surveillance model by answering questions about how patients with subclinical lymphedema should be clinically managed.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Indications for Breast Cancer-related Subclinical Lymphedema Identified Through a Bioimpedance Surveillance Model
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Compression Group

Subjects in the Compression Group will wear 20-30 mmHg sleeves and gauntlets daily for a maximum of 4 weeks. L-dex will be performed at the end of each week. If the L-dex score has reversed back into normal range, intervention (garment wearing) will be discontinued and the subject will resume the surveillance schedule of screenings. If the L-dex score is still abnormal, garment wearing continues. If L-dex score is abnormal even at the end of the 4 weeks, the subject will be removed from the study and referred to standard lymphedema therapy.

An abnormal L-dex is defined by 7 or more units change compared to the subject's pre-surgical baseline.

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.


Experimental: Therapy Group

Subjects in the Therapy Group will wear 20-30 mmHg sleeves and gauntlets daily and receive Manual Lymphatic Drainage 3x/week for a maximum of 4 weeks. L-dex will be performed at the end of each week. If the L-dex score has reversed back into normal range, intervention will be discontinued and the subject will resume the surveillance schedule of screenings. If the L-dex score is abnormal, intervention continues. If L-dex score is abnormal even at the end of the 4 weeks, the subject will be removed from the study and referred to standard lymphedema therapy.

An abnormal L-dex is defined by 7 or more units change compared to the subject's pre-surgical baseline.

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.

Other Name: MLD




Primary Outcome Measures :
  1. L-dex scores [ Time Frame: 3 years post-operatively ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer diagnosis, female, 18 years of age or older, upcoming unilateral sentinel lymph node biopsy or axillary lymph node dissection, able to provide informed consent

Exclusion Criteria:

  • pre-existing diagnosis of lymphedema as diagnosed by physician, previous history of breast cancer, history of axillary surgery on either side, pregnancy, pacemaker or other implanted electrical device, Stage 4 or 5 kidney disease, severe liver disease, active infection, acute deep vein thrombosis, unmanaged congestive heart failure or a cardiac event in the past 6 months, prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292198


Contacts
Layout table for location contacts
Contact: Megan T Klote, DPT, CLT-LANA 314-399-8822 megan.klote@mercy.net
Contact: Sarah Stolker, MSPT, CLT-LANA sarah.stolker@mercy.net

Locations
Layout table for location information
United States, Missouri
Mercy David C. Pratt Cancer Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Megan Klote, DPT, CLT-LANA         
Sponsors and Collaborators
Mercy Research
Mercy Foundation
St. Louis Men's Group Against Cancer
ImpediMed Limited
Juzo USA
Investigators
Layout table for investigator information
Principal Investigator: Megan T Klote, DPT, CLT-LANA Mercy Research

Layout table for additonal information
Responsible Party: Megan Klote, Doctor of Physical Therapy, Certified Lymphedema Therapist - LANA, Mercy Research
ClinicalTrials.gov Identifier: NCT03292198     History of Changes
Other Study ID Numbers: 1070741-1
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Megan Klote, Mercy Research:
Subclinical lymphedema
bioimpedance
breast cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases