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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population

Conditions
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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, Head and Neck Carcinoma, Stage II Hypopharyngeal Carcinoma AJCC v8, Stage II Laryngeal Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8, Stage III Laryngeal Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Hypopharyngeal Carcinoma AJCC v8, Stage IV Laryngeal Cancer AJCC v8, Stage IV Lip and Oral Cavity Cancer AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Intervention / Treatment
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* Other: Best Practice
* Other: Consensus Auditory-Perceptual Evaluation of Voice
* Procedure: Diagnostic Imaging
* Other: Lymphedema Management
* Procedure: Modified Barium Swallow
* Procedure: Nasopharyngeal Laryngoscopy
* Device: Pneumatic Compression Therapy
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Voice Handicap Index-10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (pneumatic therapy, lymphedema management)<br>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. | Other: Consensus Auditory-Perceptual Evaluation of Voice<br>* Ancillary studies<br>* Other names: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V);Procedure: Diagnostic Imaging<br>* Undergo photographs of face and neck<br>* Other names: Medical Imaging;Other: Lymphedema Management<br>* Undergo skilled lymphedema treatment by a therapist<br>Procedure: Modified Barium Swallow<br>* Undergo swallow study<br>* Other names: Videofluoroscopic Swallowing Study;Procedure: Nasopharyngeal Laryngoscopy<br>* Undergo Nasolaryngoscopy<br>Device: Pneumatic Compression Therapy<br>* 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.<br>* Other names: Flexi-touch Plus System;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Voice Handicap Index-10<br>* Ancillary studies<br>* Other names: Voice Handicap Index-10 (VHI-10);|
| Active Comparator: Group II (standard of care, lymphedema management)<br>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. | Other: Best Practice<br>* Undergo self-manual lymphatic drainage<br>* Other names: standard therapy;Other: Consensus Auditory-Perceptual Evaluation of Voice<br>* Ancillary studies<br>* Other names: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V);Procedure: Diagnostic Imaging<br>* Undergo photographs of face and neck<br>* Other names: Medical Imaging;Other: Lymphedema Management<br>* Undergo skilled lymphedema treatment by a therapist<br>Procedure: Modified Barium Swallow<br>* Undergo swallow study<br>* Other names: Videofluoroscopic Swallowing Study;Procedure: Nasopharyngeal Laryngoscopy<br>* Undergo Nasolaryngoscopy<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Voice Handicap Index-10<br>* Ancillary studies<br>* Other names: Voice Handicap Index-10 (VHI-10);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare composite measurements of the face and neck for lymphatic drainage | 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 from baseline and up to 12 weeks | 
| Change in lymphedema of the head and neck | 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. | Up to 12 weeks | 

Secondary Outcome Measures

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