Clinical trial NCT03292198: Subclinical Lymphedema Treatment Study
Official title: Treatment Indications for Breast Cancer-related Subclinical Lymphedema Identified Through a Bioimpedance Surveillance Model
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer-related Subclinical Lymphedema
Keywords: Subclinical lymphedema
bioimpedance
breast cancer
Lead sponsor: Mercy Research
Sponsor class: OTHER
Collaborators: name: Mercy Foundation
name: St. Louis Men's Group Against Cancer
name: ImpediMed Limited
name: Juzo USA
First posted: 2017-09-25
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: L-dex scores
timeFrame: 3 years post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy David C. Pratt Cancer Center
state: Missouri
Study officials:
affiliation: Mercy Research
name: Megan T Klote, DPT, CLT-LANA
role: PRINCIPAL_INVESTIGATOR
References: