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Lymphedema Treatment in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexitouch Plus system
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Lymphedema, Treatment

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2020
Last Updated
August 11, 2020
Sponsor
NorthShore University HealthSystem
Collaborators
Tactile Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04276454
Brief Title
Lymphedema Treatment in Head and Neck Cancer Patients
Official Title
Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Per investigator's request.
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Tactile Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and Neck Cancer, Lymphedema, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive a single intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Flexitouch Plus system
Intervention Description
A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.
Primary Outcome Measure Information:
Title
Internal lymphedema measurement
Description
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
External lymphedema measurement
Description
Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device).
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihir Bhayani, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lymphedema Treatment in Head and Neck Cancer Patients

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