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NCT Number: NCT03916809

EMST in Patients Undergoing CRT for HNCA

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).

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Key information

Conditions

Head and Neck Neoplasms Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert Hospital, Milwaukee, Wisconsin, United States

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About this study

Thirty (30) persons with newly-diagnosed HNCA who will be treated with RT/CRT will be randomized to an 8-week program of either Active Expiratory Muscle Strength Training (EMST) + Standard Care or Sham EMST + Standard Care in order to examine the impact of EMST on swallowing function. The training program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks, coincident with RT/CRT. Patients randomized to the Active EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Those randomized to the Sham EMST group will use an EMST150 device that has been modified to eliminate resistance to airflow.

All subjects will be evaluated prior to initiation of cancer treatment (baseline assessment), 4 weeks into cancer treatment and again at the completion of cancer treatment (8 weeks after initiation of treatment). Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, and administration of swallow-related quality of life (QOL) questionnaires.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMST

Other

Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.

Primary outcomes

  1. Feeding-tube-free food intake (days)

    Time frame: 8 weeks

    the number of days from the beginning of the study until change in feeding status from 100% oral intake to combined oral intake and tube intake and/or 100% tube feeding will be calculated

Secondary outcomes

  1. Penetration-Aspiration Scale rating (number)

    Time frame: 8 weeks

    From Videofluoroscopic Swallow Studies (VFSS), change in Penetration-Aspiration scale score will be determined from baseline to mid-treatment to post-treatment. Penetration-Aspiration Scale is an 8-point ordinal rating scale.

  2. Timing of Aspiration (category)

    Time frame: 8 weeks

    From Videofluoroscopic Swallow Studies (VFSS), timing of aspiration will be determined from baseline to mid-treatment to post-treatment. Timing is identified as a category, either before, during, or after.

  3. Presence of pharyngeal residue (dichotomous)

    Time frame: 8 weeks

    From Videofluoroscopic Swallow Studies (VFSS), the presence of residue in the pharynx (yes or no) will be determined from baseline to mid-treatment to post-treatment.

  4. Extent of hyoid movement (mm)

    Time frame: 8 weeks

    From Videofluoroscopic Swallow Studies (VFSS), the change in extent of hyoid movement in mm will be determined from baseline to mid-treatment to post-treatment.

  5. Upper esophageal sphincter (UES) opening width (mm)

    Time frame: 8 weeks

    From Videofluoroscopic Swallow Studies (VFSS), the change in width of UES opening width in mm will be determined from baseline to mid-treatment to post-treatment.

Other outcomes

  1. Eating Assessment Tool (EAT-10) (number)

    Time frame: 8 weeks

    Change in score on the EAT-10 will be calculated from baseline to mid-treatment to post-treatment. EAT-10 is an ordinal rating scale with values that range from 0 to 40, with lower score reflecting better function.

  2. M.D. Anderson Dysphagia Inventory (MDADI) (number)

    Time frame: 8 weeks

    Change in scores on the M.D. Anderson Dysphagia Inventory (MDADI) will be calculated from baseline to mid-treatment to post-treatment. MDADI consists of four ordinal rating scales with scores ranging from 0 to 100 with higher score reflecting better function.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Pauloski, Ph.D.

CONTACT

[email protected]

4142296719

Stephanie Stevens, M.S.

CONTACT

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Collaborators

  • Froedtert Hospital
  • Medical College of Wisconsin

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2019
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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