A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation
Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage III HPV-Mediated (p16-pos) Oropharyngeal Carcinoma, Clinical Stage IV HPV-Mediated (p16-pos)Oropharyngeal Carcinoma
About this trial
This is an interventional treatment trial for Clinical Stage II HPV-Mediated (p16-pos) Oropharyngeal Carcinoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group I (pneumatic therapy, lymphedema management)
Group II (standard of care, lymphedema management)
Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.