A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

Tactile Medical49 enrolled

Overview

The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.

This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. The study will be conducted at up to 2 sites in the United States and enroll 40 subjects with a diagnosis of head and neck lymphedema following treatment for head and neck cancer. Subjects randomized to receive daily treatment with the Flexitouch pneumatic compression device and home care regimen (SOC) will be seen at baseline and weeks 1, 4, and 8. Subjects randomized to the wait list arm will be seen at baseline and weeks 1, 4, and 8 while receiving SOC treatment. Assessments will include fidelity, satisfaction, symptoms, swelling/inflammation, function, and QOL.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms Head and Neck Cancer Head and Neck Lymphedema

Interventions

Flexitouch head and neck lymphedema treatment systemDEVICE

Pneumatic compression device cleared for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: lymphedema; primary lymphedema; post mastectomy edema; edema following trauma and sports injuries; post immobilization edema; venous insufficiency; reducing wound healing time; treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. The Flexitouch system and garments for head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Standard home lymphedema careOTHER

May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * A previous diagnosis of histologically defined head and neck cancer. * A diagnosis of head and neck lymphedema. * Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation. * Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved. * The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy. * The subject must have experienced at least one of the following: * Completion of phase 1 lymphedema care in the past 8 weeks; * The inability to participate/complete phase 1 care due to: * Lack of available therapist/clinic, * Lack of insurance coverage or funding to support cost of care. Exclusion Criteria: * Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression). * 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). * Symptomatic bradycardia in the absence of a pacemaker. * Internal jugular venous thrombosis, acute or within 3 months. * Increased intracranial pressure or other contraindications to internal or external jugular venous compression. * Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative. * Facial or head and neck dermal metastasis. * Acute facial infection (e.g., facial or parotid gland abscess). * Any condition in which increased venous and lymphatic return is undesirable. * History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment. * Subject is pregnant or trying to become pregnant.

Locations (2)

SIU School of Medicine

Springfield, Illinois, United States

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Fidelity/Adherence Via Subject Diary

Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.

Time frame: From baseline to end of treatment at 8 weeks

Adverse Events

Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.