CompletedNot Applicable

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

United States236 participantsStarted 2021-09-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Internal Lymphedema - Endoscopy

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

Internal Lymphedema - CT Imaging

Timeframe: Change from Baseline at 2 months, 6 months

Internal Lymphedema - CT Imaging

Timeframe: Change from Baseline at 2 months, 6 months

External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading

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

External Lymphedema - Digital Photography

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

Symptom Burden - Lymphedema Symptom Intensity and Distress Survey

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

Physical Function - Vanderbilt Head and Neck Symptom Survey

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

Quality of Life - Linear Analog Self-Assessment

Trial details

NCT IDNCT04797390

SponsorTactile Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-03

Results submitted2025-12-03

View on ClinicalTrials.gov More Lymphedema trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Internal Lymphedema - Endoscopy

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

Internal Lymphedema - CT Imaging

Timeframe: Change from Baseline at 2 months, 6 months

Internal Lymphedema - CT Imaging

Timeframe: Change from Baseline at 2 months, 6 months

External Lymphedema - Head and Neck Lymphedema and Fibrosis Grading

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

External Lymphedema - Digital Photography

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

Symptom Burden - Lymphedema Symptom Intensity and Distress Survey

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

Physical Function - Vanderbilt Head and Neck Symptom Survey

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

Quality of Life - Linear Analog Self-Assessment