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

Completed · Not applicable

Conditions studied: Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Lymphedema

In brief

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.

Key facts

Study ID

NCT03332160

Run by

Tactile Medical

People needed

49

Starts

2018-01-02

Expected to finish

2019-07-31

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SIU School of Medicine — Springfield, Illinois, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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