Lymphedema Treatment in Head and Neck Cancer Patients

NorthShore University HealthSystem

Status: Withdrawn

Conditions: Head and Neck Cancer

Treatments: Device: Flexitouch Plus system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04276454

EH19-199

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single arm

Experimental group

Treatment:

Device: Flexitouch Plus system