A Pneumatic Compression Device for the Treatment of Lymphedema in Patients With Stage II-IV Head and Neck Cancer After Chemoradiation

PRIMARY OBJECTIVES:

I. Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD.

II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: 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.

GROUP II: 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.

• Best Practice (Other), also known as standard of care, standard therapy: Undergo self-manual lymphatic drainage
• Consensus Auditory-Perceptual Evaluation of Voice (Other), also known as CAPE-V, Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V): Ancillary studies
• Diagnostic Imaging (Procedure), also known as Medical Imaging: Undergo photographs of face and neck
• Lymphedema Management (Other): Undergo skilled lymphedema treatment by a therapist
• Modified Barium Swallow (Procedure), also known as MBS, VFSS, Videofluoroscopic Swallowing Study: Undergo swallow study
• Nasopharyngeal Laryngoscopy (Procedure): Undergo Nasolaryngoscopy
• Pneumatic Compression Therapy (Device), also known as Flexi-touch Plus System: Undergo compression therapy - Flexitouch Plus System is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides systematic and sequential pressure changes to move fluid to intact lymphatic chains.
• Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Ancillary studies
• Questionnaire Administration (Other): Ancillary studies
• Voice Handicap Index-10 (Other), also known as VHI-10, Voice Handicap Index-10 (VHI-10): Ancillary studies

Primary outcomes

• Compare composite measurements of the face and neck for lymphatic drainage [Change from baseline and up to 12 weeks]: Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.
• Change in lymphedema of the head and neck [Up to 12 weeks]: A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.

Secondary outcomes

• Improvements on quality of life (QOL) function [Up to 12 weeks]: Measured by QOL questionnaire and Facial and Neck Composite Measurements Status Scale: PSS-HN
• Improvements on voice function [Up to 12 weeks]: Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
• Improvements on swallowing function [Up to 12 weeks]: Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance

Sex: All, ages: 18 Years to any

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

• Lisa Crujido, Principal investigator, Mayo Clinic