A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema

Tactile Medical236 enrolled

Overview

To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.

Aim 1: To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on anatomical measures of internal and external LEF. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term reduction in anatomical measures of LEF. Aim 2: To compare the short-term and long-term effectiveness of self-administered APCD therapy versus Usual Care in HNC survivors with treatment naive LEF on patient reported biopsychosocial outcome measures impacted by LEF. Outcome measures will include: 1) symptom burden, 2) symptom burden and functional impairment, 3) quality of life (QOL), 4) work and activity, 5) perceived self-management capacity, 6) body image, and 7) diet modifications. Baseline measures will be obtained at the start of therapy. Short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. Hypothesis: the APCD therapy will be associated with greater short-term and long-term improvement in patient reported biopsychosocial outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

236

Conditions

Lymphedema Lymphedema of Face Lymphedema, Secondary Lymphedema Due to Radiation Lymphedema; Surgical

Interventions

Advanced Pneumatic Compression Device (APCD)DEVICE

Once daily treatment with Flexitouch Plus.

Usual CareOTHER

Usual care consists of a two-phase CDT. Phase 1 includes consultation with a lymphedema therapist, patient education, MLD, compression garments or bandages, skin care techniques, and a program of exercises and postural recommendations. Phase 2 consists of ongoing self-care, where patients conduct a life-long program of disease management that mimics the program in phase 1.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years 2. Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary) 3. Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment 4. A diagnosis of either internal or external head and neck lymphedema 5. At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening 6. Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation 7. Must be able to speak and understand English Exclusion Criteria: 1. Previous APCD or Usual Care treatment for HNC LEF 2. Acute facial infection (e.g., facial or parotid gland abscess) 3. Known carotid sinus hypersensitivity syndrome 4. Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness) 5. Internal jugular venous thrombosis (within 3 months) 6. Patient is pregnant or trying to become pregnant

Locations (10)

University of Alabama

Birmingham, Alabama, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Reduction in Swelling/Inflammation - Endoscopy

The change in percent of sites with visible swelling and inflammation as assessed via endoscopy (using Modified Patterson Scale). The range for each anatomical structure includes 1-4: Normal, Mild, Moderate, and Severe. A lower score means a better outcome. A greater negative value indicates a greater reduction in swelling. Total score range: 0-100%

Time frame: Changes between Baseline, 2 months, 4 months, 6 months

Reduction in Swelling/Imaging - CT

The changes in fat stranding, epiglottic thickness, and prevertebral soft tissue (PVST) using the CT Lymphedema and Fibrosis Assessment Tool (CT-LEFAT). The range for fat stranding includes 0-2: Normal, Mild Changes, Advanced Changes. A lower score means a better outcome. Epiglottis and PVST are measured in mm. A lower measurement means a better outcome.

Time frame: Changes between Baseline, 2 months, 6 months

Reduction in Swelling/Inflammation - Grading of External Lymphedema

The presence of swelling and inflammation as assessed through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Assessment criteria (HNLEF). A total of 9 sites are evaluated for the presence of lymphedema and graded from 1 (mild) to 3 (severe) at each site. The number of sites ranged from 0-9 with a total severity score ranging from 0-27. A lower score indicates a better outcome. A greater negative value indicates a greater reduction in swelling.

Time frame: Changes between Baseline, 2 months, 4 months, 6 months

Reduction in Swelling/Inflammation - Digital Photography

The presence of swelling and inflammation are assessed by digital photography. A lower value means a better outcome. A greater negative value indicates a greater reduction in swelling. Three views are scored each with 30 grids. The percentage of views with visible swelling was determined. The score ranges from 0-100%.

Time frame: Changes between Baseline, 2 months, 4 months, 6 months

Symptom Burden - Lymphedema Symptom Intensity and Distress Survey

Data from ClinicalTrials.gov

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