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

NCT ID: NCT03332160

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2019-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard home lymphedema care

Group Type: ACTIVE_COMPARATOR

Standard home lymphedema care

Intervention Type: OTHER

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

Flexitouch head and neck lymphedema treatment system

Daily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care

Group Type: EXPERIMENTAL

Flexitouch head and neck lymphedema treatment system

Intervention Type: DEVICE

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.

Interventions

Flexitouch head and neck lymphedema treatment system

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.

Intervention Type: DEVICE

Standard home lymphedema care

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

Intervention Type: OTHER

Other Intervention Names

Flexitouch System

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

Tactile Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila Ridner, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Nursing

Locations

SIU School of Medicine

Springfield, Illinois, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

4030

Identifier Type: -

Identifier Source: org_study_id