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

NCT04797390 | Completed Results FDA Device

• 1 other identifier: 8030
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

Head and Neck Lymphedema

Outcome Measures

Primary Outcomes (13)

• Internal Lymphedema - Endoscopy

  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.

  Change from Baseline at 2 months, 4 months, 6 months

• Internal Lymphedema - CT Imaging

  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.

  Change from Baseline at 2 months, 6 months

• Internal Lymphedema - CT Imaging

  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.

  Change from Baseline at 2 months, 6 months

• External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading

  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.

  Change from Baseline at 2 months, 4 months, 6 months

• External Lymphedema - 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%.

  Change from Baseline at 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 (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.

  Change from Baseline at 2 months, 4 months, 6 months

• Physical Function - 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.

  Change from Baseline at 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 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.

  Change from Baseline at 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. The values represent the difference from baseline percentage. A greater negative number indicates a greater reduction in impairment. Total score range: 0-100%

  Change from Baseline at 2 months, 4 months, 6 months

• Perceived Self-management Capacity - Perceived Medical Condition Self-Management Scale

  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.

  Change from Baseline at 2 months, 4 months, 6 months

• Body Image - Body Image Quality of Life Inventory

  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.

  Change from Baseline at 2 months, 4 months, 6 months

• Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool

  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.

  Change from Baseline at 2 months, 4 months, 6 months

• Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool

  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.

  Change from Baseline at 2 months, 4 months, 6 months

Study Arms (2)

Advanced Pneumatic Compression Device (APCD)

ACTIVE COMPARATOR

Daily self-administered treatment with the Flexitouch® Plus system (FT)

Device: Advanced Pneumatic Compression Device (APCD)

Usual Care

ACTIVE COMPARATOR

Complete Decongestive Therapy (CDT) directed by a lymphedema therapist and any additional adjunctive measures as prescribed by the lymphedema therapist

Other: Usual Care

Interventions

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.

Also known as: Complete Decongestive Therapy (CDT), Manual Lymphatic Drainage (MLD)

Usual Care

Advanced Pneumatic Compression Device (APCD) DEVICE

Once daily treatment with Flexitouch Plus.

Also known as: Flexitouch, Flexitouch Plus

Advanced Pneumatic Compression Device (APCD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tactile Medical: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (10)

University of Alabama

Birmingham, Alabama, 35924, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Advanced Head & Neck Rehabilitation Center of Texas

Fort Worth, Texas, 76104, United States

Location

Related Publications (1)

• Murphy BA, Smith DK, Kline-Quiroz CM, Jensen KM, Sukari AW, Bhayani MK, Mehta V, Quon H, Shah JL, Willey CD, Dunlap NE, Lee HK, Aulino JM, Ridner SH. Short-Term Outcomes of Advanced Pneumatic Compression Device Versus Usual Care Therapy for Head and Neck Cancer-Related Lymphedema: A Multi-Site Randomized Clinical Trial. Head Neck. 2026 Apr;48(4):1077-1087. doi: 10.1002/hed.70155. Epub 2026 Jan 23.

  PMID: 41574713 DERIVED

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Sr. VP Marketing & Clinical Affairs
• Organization: Tactile Medical

clinicalresearch@tactilemedical.com

1.833.382.2845

Study Officials

• Barbara Murphy, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Sheila Ridner, RN, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: September 23, 2021
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)