Lymphedema Treatment in Head and Neck Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2020-04-23

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.

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will receive a single intervention.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

Flexitouch Plus system

Intervention Type DEVICE

A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.

Interventions

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Flexitouch Plus system

A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No