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Subclinical Lymphedema Treatment Study (SLT)

Primary Purpose

Breast Cancer-related Subclinical Lymphedema

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
20-30 mmHg compression sleeve and gauntlet
Manual Lymphatic Drainage
Sponsored by
Mercy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer-related Subclinical Lymphedema focused on measuring Subclinical lymphedema, bioimpedance, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

New diagnosis of breast cancer, Female, 18 years of age or older, Upcoming unilateral axillary lymph node procedure (biopsy or dissection), Able to provide informed consent

Exclusion Criteria:

Pre-existing diagnosis of lymphedema, as diagnosed by physician, History of axillary lymph node procedure, including biopsy, dissection, or radiation to, Pregnancy, Pacemaker or other implanted electrical device, Stage 4-5 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

Sites / Locations

  • Mercy David C. Pratt Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Compression Group

Therapy Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

L-dex scores

Secondary Outcome Measures

Full Information

First Posted
September 21, 2017
Last Updated
January 9, 2023
Sponsor
Mercy Research
Collaborators
Mercy Foundation, St. Louis Men's Group Against Cancer, ImpediMed Limited, Juzo USA
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1. Study Identification

Unique Protocol Identification Number
NCT03292198
Brief Title
Subclinical Lymphedema Treatment Study
Acronym
SLT
Official Title
Treatment Indications for Breast Cancer-related Subclinical Lymphedema Identified Through a Bioimpedance Surveillance Model
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research
Collaborators
Mercy Foundation, St. Louis Men's Group Against Cancer, ImpediMed Limited, Juzo USA

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer-related Subclinical Lymphedema
Keywords
Subclinical lymphedema, bioimpedance, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Therapy Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
20-30 mmHg compression sleeve and gauntlet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage
Other Intervention Name(s)
MLD
Intervention Description
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.
Primary Outcome Measure Information:
Title
L-dex scores
Time Frame
3 years post-operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New diagnosis of breast cancer, Female, 18 years of age or older, Upcoming unilateral axillary lymph node procedure (biopsy or dissection), Able to provide informed consent Exclusion Criteria: Pre-existing diagnosis of lymphedema, as diagnosed by physician, History of axillary lymph node procedure, including biopsy, dissection, or radiation to, Pregnancy, Pacemaker or other implanted electrical device, Stage 4-5 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan T Klote, DPT, CLT-LANA
Organizational Affiliation
Mercy Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy David C. Pratt Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Subclinical Lymphedema Treatment Study

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