Lymphedema Treatment in Head and Neck Cancer Patients

Not Applicable

Withdrawn

• Conditions: Head and Neck Cancer
• Interventions: Device: Flexitouch Plus system

• Registration Number: NCT04276454
• Lead Sponsor: NorthShore University HealthSystem

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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-04-23
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Flexitouch Plus system	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Chicago, Illinois, United States