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Search / Trial NCT03916809

EMST in Patients Undergoing CRT for HNCA

Launched by UNIVERSITY OF WISCONSIN, MILWAUKEE · Apr 12, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Oropharyngeal Cancer Laryngeal Cancer Swallow Chemoradiation Expiratory Muscle Strength Training

ClinConnect Summary

This clinical trial is studying how a special exercise program called expiratory muscle strength training (EMST) can help people with head and neck cancer maintain their ability to swallow safely and efficiently while undergoing radiation therapy or chemoradiotherapy. Participants will be randomly chosen to either receive the EMST training or follow standard care to see if the training makes a difference in their swallowing function.

To be eligible for this study, individuals need to be at least 18 years old and have a new diagnosis of cancer in specific areas of the head and neck, such as the oral cavity or throat. They should be planning to receive radiation treatment, with or without chemotherapy. Participants must be able to use a device called the EMST150, which is designed to help with the training. However, people who have had previous surgery for head and neck cancer or have certain neurological conditions will not be included in the trial. If you join the study, you can expect support and guidance on how to use the EMST device, along with regular evaluations of your swallowing function throughout the trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • New diagnosis of cancer in the oral cavity, oropharynx, hypopharynx, or larynx;
  • Planned treatment with primary radiotherapy with or without chemotherapy;
  • Age 18 or older and able to provide consent;
  • Ability to use the EMST150 device (hold in mouth and maintain lip seal)
  • Exclusion Criteria:
  • Primary surgery to the head and neck (neck dissection is permitted);
  • Unknown primary tumor;
  • Primary cancers of the nasopharynx, paranasal sinuses, salivary glands and skin.
  • Progressive neurologic condition affecting muscle strength (e.g. amyotrophic lateral sclerosis (ALS), Parkinson's disease)
  • Dysphagia not related to HNCA (e.g. unresolved swallowing difficulty post-stroke or post--traumatic brain injury (TBI))
  • Prior history of head and neck radiotherapy

About University Of Wisconsin, Milwaukee

The University of Wisconsin-Milwaukee (UWM) is a leading research institution dedicated to advancing knowledge and improving health outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, UWM leverages its diverse expertise in biomedical research, public health, and community engagement to conduct rigorous clinical studies. The university fosters an environment of academic excellence and ethical research practices, aiming to translate findings into real-world applications that benefit patients and communities. UWM is committed to enhancing the quality of life through scientific discovery and education, making significant contributions to the field of clinical research.

Locations

Milwaukee, Wisconsin, United States

Milwaukee, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Barbara Pauloski

Principal Investigator

University of Wisconsin, Milwaukee

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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