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

Tactile Medical

Status: Completed

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

Treatments: Device: Advanced Pneumatic Compression Device (APCD); Other: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04797390

8030 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Advanced Pneumatic Compression Device (APCD)

Active Comparator group

Description:

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

Treatment:

Device: Advanced Pneumatic Compression Device (APCD)

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care