A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head … (NCT05512767) | Clinical Trial Compass
WithdrawnNot Applicable
A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
Stopped: PI retired and study not moving forward
0Started 2022-12-01
Plain-language summary
This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.
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:
* Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
* Cognitive function adequate to understand and execute the elements of the protocol
* Willingness and ability to return to Mayo Clinic for follow-up care per protocol
* Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
* Must demonstrate oropharyngeal competency that would allow some oral intake
Exclusion Criteria:
* Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
* Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
* Acute facial infection
* Active congestive heart failure (CHF) or pulmonary edema
* Symptomatic carotid artery disease or bradycardia
* Increased intracranial pressure
* History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
* \> 50% internal carotid artery (ICA) blockage
* Upper quadrant deep vein thrombosis
* Known esophageal obstruction
* Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
* Women of child-bearing potential
* (Active) pregnancy
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
Compare composite measurements of the face and neck for lymphatic drainage
Timeframe: Change from baseline and up to 12 weeks