A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System He… (NCT03332160) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
United States49 participantsStarted 2018-01-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dermatiti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fidelity/Adherence Via Subject Diary
Timeframe: From baseline to end of treatment at 8 weeks
2
Adverse Events
Timeframe: From baseline to the end of treatment at 8 weeks
3
Treatment Satisfaction
Timeframe: From baseline to the end of treatment at 8 weeks