N/A N=236 Randomized Single-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT04797390 ↗

Enrolled (actual)

236

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Internal Lymphedema - Endoscopy — -0.12; -0.06; -0.21; -0.16 Score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Advanced Pneumatic Compression Device (APCD) (Device); Usual Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tactile Medical
Primary completion: Dec 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Internal Lymphedema - Endoscopy	-0.12; -0.06; -0.21; -0.16; -0.26; -0.23	—
PRIMARY Internal Lymphedema - CT Imaging	-0.10; -0.20; -0.60; -0.55; -0.40; -0.20	—
PRIMARY Internal Lymphedema - CT Imaging	-0.10; -0.20; -0.60; -0.55; -0.40; -0.20	—
PRIMARY External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading	-1.00; 0.00; -1.00; 0.00; -2.00; -1.00	—
PRIMARY External Lymphedema - Digital Photography	-4.55; -1.38; -4.55; -2.17; -4.17; -1.52	—
PRIMARY Symptom Burden - Lymphedema Symptom Intensity and Distress Survey	-0.26; -0.46; -0.70; -0.71; -0.56; -0.39	—
PRIMARY Physical Function - Vanderbilt Head and Neck Symptom Survey	-0.68; -0.73; -0.94; -1.01; -1.12; -1.06	—
PRIMARY Quality of Life - Linear Analog Self-Assessment	0.00; 0.00; 0.00; 1.00; 1.00; 1.00	—
PRIMARY Work and Activity - Work Productivity and Activity Impairment Questionnaire	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
PRIMARY Perceived Self-management Capacity - Perceived Medical Condition Self-Management Scale	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
PRIMARY Body Image - Body Image Quality of Life Inventory	4.0; 2.0; 3.0; 2.0; 4.0; 2.0	—
PRIMARY Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool	9.0; 13.0; 12.0; 12.0; 2.5; 11.5	—
PRIMARY Diet Modifications - Automated Self-Administered 24-Hour Dietary Assessment Tool	9.0; 13.0; 12.0; 12.0; 2.5; 11.5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04797390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.