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Completed

NCT Number: NCT04797390

A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of 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.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Due to Radiation Lymphedema of Face Lymphedema, Secondary Lymphedema; Surgical Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Pathologically confirmed cancer of the HNC (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and HNC of unknown primary)
  • Completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment
  • A diagnosis of either internal or external head and neck lymphedema
  • At least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening
  • Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation
  • Must be able to speak and understand English

Exclusion criteria

  • Previous APCD or Usual Care treatment for HNC LEF
  • Acute facial infection (e.g., facial or parotid gland abscess)
  • Known carotid sinus hypersensitivity syndrome
  • 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)
  • Internal jugular venous thrombosis (within 3 months)
  • Patient is pregnant or trying to become pregnant

Treatment and study plan

Advanced Pneumatic Compression Device (APCD)

Device

Once daily treatment with Flexitouch Plus.

Other names: Flexitouch, Flexitouch Plus

Usual Care

Other

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)

Primary outcomes

  1. Internal Lymphedema - Endoscopy

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    The change in average site score from baseline assessed via endoscopy using the Modified Patterson Scale. The range for each site was 0-3: Normal, Mild, Moderate, Severe. A lower score means a better outcome.

  2. Internal Lymphedema - CT Imaging

    Time frame: Change from Baseline at 2 months, 6 months

    The changes in fat stranding 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.

  3. Internal Lymphedema - CT Imaging

    Time frame: Change from Baseline at 2 months, 6 months

    The changes in epiglottic thickness, and prevertebral soft tissue (PVST) using the CT Lymphedema and Fibrosis Assessment Tool (CT-LEFAT). Epiglottis and PVST are measured in mm. A lower measurement means a better outcome.

  4. External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    The presence of swelling and inflammation as assessed through grading of external lymphedema via the Head and Neck Lymphedema and Fibrosis Grading criteria (HN-LEFG). 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.

  5. External Lymphedema - Digital Photography

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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%.

  6. Symptom Burden - Lymphedema Symptom Intensity and Distress Survey

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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 (1-Slight to 5-Severe), then added together. The values represent the mean score change from baseline. Score range: 0-10 (0 = symptom not present). A lower score means a better outcome.

  7. Physical Function - Vanderbilt Head and Neck Symptom Survey

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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.

  8. Quality of Life - Linear Analog Self-Assessment

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    Quality of life is assessed using the Linear Analog Self-Assessment. The overall well-being score ranges from 0-10 (0-As bad as it can be to 10-As good as it can be). The value represents the change from baseline. A positive change indicates an improvement.

  9. Work and Activity - Work Productivity and Activity Impairment Questionnaire

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    Work Productivity and Activity Impairment Questionnaire (WPAIQ) PRO assessment asks questions about work and activity impairment due to lymphedema and other health problems. The values represent the difference from baseline percentage. A greater negative number indicates a greater reduction in impairment. Total score range: 0-100%

  10. Perceived Self-management Capacity - Perceived Medical Condition Self-Management Scale

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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.

  11. Body Image - Body Image Quality of Life Inventory

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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. The values represent the change from baseline. A higher score indicates a better outcome.

  12. Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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 will be evaluated.

  13. Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool

    Time frame: Change from Baseline at 2 months, 4 months, 6 months

    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 fat, carbohydrate, fiber, sugars, and protein will be evaluated.

Sponsors and collaborators

Lead sponsor

Tactile Medical

Industry

Collaborators

  • Vanderbilt University Medical Center

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2021
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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