NCT04276454

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

Same day

First QC Date

February 17, 2020

Last Update Submit

August 11, 2020

Conditions

Head and Neck Cancer

Keywords

Head and Neck CancerLymphedemaTreatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • External lymphedema measurement

    2 hours

Study Arms (1)

Single arm

EXPERIMENTAL
Device: Flexitouch Plus system

Interventions

Flexitouch Plus systemDEVICE

A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.

Single arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • to 100 years of age

You may not qualify if:

  • Significant surgical resection of pharyngeal constrictor muscles
  • Patients with persistent or recurrent disease
  • Patients who have contraindications to use Flexitouch Plus device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Chicago, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphedema

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Mihir Bhayani, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All subjects will receive a single intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

April 23, 2020

Primary Completion

April 23, 2020

Study Completion

April 23, 2020

Last Updated

August 13, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)