Clinical trial NCT04797390: A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
Official title: A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lymphedema of Face
Lymphedema, Secondary
Lymphedema Due to Radiation
Lymphedema; Surgical
Keywords: Head and Neck Lymphedema
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University Medical Center
First posted: 2021-03-15
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Swelling/Inflammation - Endoscopy
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Reduction in Swelling/Imaging - CT
timeFrame: Changes between Baseline, 2 months, 6 months
measure: Reduction in Swelling/Inflammation - Grading of External Lymphedema
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Reduction in Swelling/Inflammation - Digital Photography
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Symptom Burden - Lymphedema Symptom Intensity and Distress Survey
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Symptom Burden and Functional Impairment - Vanderbilt Head and Neck Symptom Survey
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Quality of Life - Linear Analog Self-Assessment
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Work and Activity - Work Productivity and Activity Impairment Questionnaire
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS)
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Body image - Body Image Quality of Life Inventory (BIQLI)
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
measure: Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
timeFrame: Changes between Baseline, 2 months, 4 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Advanced Head & Neck Rehabilitation Center of Texas
state: Texas
Study officials:
affiliation: Vanderbilt University Medical Center
name: Barbara Murphy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Sheila Ridner, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: