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

A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema; Lymphedema, Secondary; Lymphedema; Surgical; Lymphedema of Face; Lymphedema Due to Radiation
• Intervention / Treatment: Device: Advanced Pneumatic Compression Device (APCD); Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35924
      • Recruiting
      • University Of Alabama
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Thomas Ow, MD; Email: THOW@montefiore.org
    • Staten Island, New York, United States, 10310
      • Recruiting
      • Richmond University Medical Center
      • Contact: Hoon Lee, MD; Email: HoLee@RUMCSI.org
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Advanced Head & Neck Rehabilitation Center of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Advanced Pneumatic Compression Device (APCD); Daily self-administered treatment with the Flexitouch® Plus system (FT)	Device: Advanced Pneumatic Compression Device (APCD); Once daily treatment with Flexitouch Plus.; Other Names: Flexitouch Plus; Flexitouch
Active Comparator: Usual Care; Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist	Other: Usual Care; 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.; Other Names: Complete Decongestive Therapy (CDT); Manual Lymphatic Drainage (MLD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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.	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.	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%.	Changes between Baseline, 2 months, 4 months, 6 months
Symptom Burden - Lymphedema Symptom Intensity and Distress Survey	Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN) assesses the measurement characteristics of a symptom burden for participants with head and neck lymphedema. Each symptom is rated on intensity and distress using a 5-point scale. A maximum response for any symptom within a given cluster will be used for the analysis. The total score ranged from 0-10. The values represent a change from baseline. A lower score means a better outcome.	Changes between Baseline, 2 months, 4 months, 6 months
Symptom Burden and Functional Impairment - Vanderbilt Head and Neck Symptom Survey	Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey (VHNSS plus GSS) assesses symptom burden and functional impairment. Values represent a median score change from baseline. Score range: 0-10. A lower score indicates a better outcome. A more negative value indicates a greater change from baseline.	Changes between Baseline, 2 months, 4 months, 6 months
Quality of Life - Linear Analog Self-Assessment	Quality of life is assessed using the Linear Analog Self-Assessment. The total score for the assessment ranges from 0-50. Each category represents a change in score from the baseline visit which ranged from positive 4 to negative 4. A positive change indicates an improvement.	Changes between Baseline, 2 months, 4 months, 6 months
Work and Activity - Work Productivity and Activity Impairment Questionnaire	Work Productivity and Activity Impairment Questionnaire (WPAIQ) PRO assessment asks questions about work and activity impairment due to lymphedema and other health problems. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. Total score range: 0-100%	Changes between Baseline, 2 months, 4 months, 6 months
Perceived self-management capacity - Perceived Medical Condition Self-Management Scale (PMCSMS)	The 8-item Perceived Medical Condition Self-Management Scale (PMCSMS) is intended to measure patients' belief that they are capable of carrying out the self-management behaviors required by their medical condition. The scale is composed of four positively worded items and four negatively worded items, each rated on a five-point Likert scale (1=Strongly Disagree to 5=Strongly Agree). Negatively worded items are reversed scored, yielding a total score ranging from 8 to 40, with a higher score indicating stronger belief of perceived self-management competence.	Changes between Baseline, 2 months, 4 months, 6 months
Body image - Body Image Quality of Life Inventory (BIQLI)	Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7 point scale ranging from -3 (very negative) to +3 (very positive). Score range: -57 to 57. A higher score indicates a better outcome.	Changes between Baseline, 2 months, 4 months, 6 months
Diet modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	Diet modifications will be assessed using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). The ASA24 is a tool from National Cancer Institute (NCI) that enables multiple automatically coded self-administered 24-hour recalls and food records. Changes in total caloric intake, fat, carbohydrate, fiber, sugars, and protein will be evaluated.	Changes between Baseline, 2 months, 4 months, 6 months

Collaborators and Investigators

• Sponsor: Tactile Medical
• Collaborators: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Head and Neck Lymphedema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 8030 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No