Lymphedema Treatment in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.

Detailed Description
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Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device.

Official Title
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Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: Flexitouch Plus system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan Both male and females 18 to 100 years of age Exclusion Criteria: Significant surgical resection of pharyngeal constrictor muscles Patients with persistent or recurrent disease Patients who have contraindications to use Flexitouch Plus device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive a single intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Device: Flexitouch Plus system<br>* A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal lymphedema measurement | The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| External lymphedema measurement | Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer, Lymphedema, Treatment