Status:
COMPLETED
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
Lead Sponsor:
Tactile Medical
Collaborating Sponsors:
Vanderbilt University
Conditions:
Head and Neck Neoplasms
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 diagnosi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03332160
Start Date
January 2 2018
End Date
July 31 2019
Last Update
August 6 2020
Active Locations (2)
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1
SIU School of Medicine
Springfield, Illinois, United States, 62702
2
Vanderbilt University
Nashville, Tennessee, United States, 37240