NCT04276454

Lymphedema Treatment in Head and Neck Cancer Patients

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Flexitouch Plus system	A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.

Timeline

• Start date: 2020-04-23
• Primary completion: 2020-04-23
• Completion: 2020-04-23
• First posted: 2020-02-19
• Last updated: 2020-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study