Lymphedema Treatment in Head and Neck Cancer Patients

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04276454

Enrollment

Registered

2020-02-19

Start date

2020-04-23

Completion date

2020-04-23

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer, Lymphedema, Treatment

Brief summary

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

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.

Interventions

DEVICEFlexitouch Plus system

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

All subjects will receive a single intervention.

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Internal lymphedema measurement	2 hours	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).

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026