EMST for Head and Neck Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Head and Neck Cancers+1 MoreEMST - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether expiratory muscle strength training can help people with cancer of the head and neck who are undergoing radiation therapy or chemoradiotherapy to maintain efficient and safe swallowing function.

Eligible Conditions
  • Head and Neck Cancers
  • Swallowing Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 8 weeks

8 weeks
Eating Assessment Tool (EAT-10) (number)
Extent of hyoid movement (mm)
Feeding-tube-free food intake (days)
M.D. Anderson Dysphagia Inventory (MDADI) (number)
Penetration-Aspiration Scale rating (number)
Presence of pharyngeal residue (dichotomous)
Timing of Aspiration (category)
Upper esophageal sphincter (UES) opening width (mm)

Trial Safety

Trial Design

2 Treatment Groups

Active EMST + Standard Care
1 of 2
Sham EMST + Standard Care
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: EMST · Has Placebo Group · N/A

Active EMST + Standard Care
Other
Experimental Group · 1 Intervention: EMST · Intervention Types: Other
Sham EMST + Standard Care
Other
ShamComparator Group · 1 Intervention: EMST · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

Froedtert HospitalOTHER
7 Previous Clinical Trials
2,786 Total Patients Enrolled
Medical College of WisconsinOTHER
561 Previous Clinical Trials
1,153,263 Total Patients Enrolled
University of Wisconsin, MilwaukeeLead Sponsor
46 Previous Clinical Trials
6,349 Total Patients Enrolled
Barbara PauloskiPrincipal Investigator - University of Wisconsin, Milwaukee
University of Wisconsin, Milwaukee

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old to consent to sexual activity.
The ability to use the EMST150 device is the ability to hold it in your mouth and maintain a lip seal.
Patients with a new diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx should be considered for enrollment in a clinical trial.
Treatment with radiotherapy and chemotherapy.