EMST in Patients Undergoing CRT for HNCA

NCT03916809 | Recruiting

• 1 other identifier: PRO29168
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feeding-tube-free food intake (days)

  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

  8 weeks

Secondary Outcomes (5)

• Penetration-Aspiration Scale rating (number)

  8 weeks

• Timing of Aspiration (category)

  8 weeks

• Presence of pharyngeal residue (dichotomous)

  8 weeks

• Extent of hyoid movement (mm)

  8 weeks

• Upper esophageal sphincter (UES) opening width (mm)

  8 weeks

Other Outcomes (2)

• Eating Assessment Tool (EAT-10) (number)

  8 weeks

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

  8 weeks

Study Arms (2)

Active EMST + Standard Care

EXPERIMENTAL

Patients randomized to the Active EMST + Standard Care arm (ACTIVE) will use the EMST150 device as packaged, i.e. following package instructions with a device that has its valve spring maintained.

Other: EMST

Sham EMST + Standard Care

SHAM COMPARATOR

Those randomized to the Sham EMST + Standard Care arm (SHAM) will use an EMST150 device that has been modified by removing the internal spring, which allows the valve to open in response to airflow through the device regardless of the amount of pressure generated.

Other: EMST

Interventions

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.

Active EMST + Standard Care; Sham EMST + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• Froedtert Hospital: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (2)

University of Wisconsin Milwaukee

Milwaukee, Wisconsin, 53211, United States

ACTIVE NOT RECRUITING

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders; Oropharyngeal Neoplasms; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Stomatognathic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Barbara Pauloski

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Pauloski, Ph.D.

CONTACT

4142296719; pauloski@uwm.edu

Stephanie Stevens, M.S.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will not know whether the device that they are given has a functioning valve spring or whether the valve spring has been removed. Researchers assessing the outcomes will not know the arm to which the subject was randomized.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects 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.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: July 12, 2017
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)