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 range18 Years

SexALL

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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

What they're measuring

Compare composite measurements of the face and neck for lymphatic drainage

Timeframe: Change from baseline and up to 12 weeks

Change in lymphedema of the head and neck

Timeframe: Up to 12 weeks

Trial details

NCT IDNCT05512767

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-22