Lymphedema Treatment in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04276454
• Other study ID #: EH19-199
• Status: Withdrawn
• Phase: N/A
• Start date: April 23, 2020
• Est. completion date: April 23, 2020

Study information

• Verified date: August 2020
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema

Intervention

Device:
• Flexitouch Plus system
A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Tactile Medical

Country where clinical trial is conducted

United States, 

Outcome

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