RECRUITING

EMST in Patients Undergoing CRT for HNCA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on maintenance of safe and efficient oropharyngeal swallow function in persons with cancer of the head and neck (HNCA) undergoing treatment with radiation therapy or chemoradiotherapy (RT/CRT).

Official Title

Impact of Expiratory Muscle Strength Training (EMST) on Swallowing Function in Persons Undergoing Radiotherapy With or Without Chemotherapy (CRT) for Cancers of the Head and Neck (HNCA)

Quick Facts

Study Start:2017-07-12
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03916809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx;
  2. * Planned treatment with primary radiotherapy with or without chemotherapy;
  3. * Age 18 or older and able to provide consent;
  4. * Ability to use the EMST150 device (hold in mouth and maintain lip seal)
  1. * Primary surgery to the head and neck (neck dissection is permitted);
  2. * Unknown primary tumor;
  3. * Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin.
  4. * Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease)
  5. * Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI))
  6. * Prior history of head and neck radiotherapy

Contacts and Locations

Study Contact

Barbara Pauloski, Ph.D.
CONTACT
4142296719
pauloski@uwm.edu
Stephanie Stevens, M.S.
CONTACT

Principal Investigator

Barbara Pauloski
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Milwaukee

Study Locations (Sites)

University of Wisconsin Milwaukee
Milwaukee, Wisconsin, 53211
United States
Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Milwaukee

  • Barbara Pauloski, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Milwaukee

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-12
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2017-07-12
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

  • oropharyngeal cancer
  • laryngeal cancer
  • swallow
  • chemoradiation
  • expiratory muscle strength training

Additional Relevant MeSH Terms

  • Head and Neck Neoplasms
  • Deglutition Disorders