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EMST in Patients Undergoing CRT for HNCA

Primary Purpose

Head and Neck Neoplasms, Deglutition Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMST
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring oropharyngeal cancer, laryngeal cancer, swallow, chemoradiation, expiratory muscle strength training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Milwaukee
  • Froedtert HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active EMST + Standard Care

Sham EMST + Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Penetration-Aspiration Scale rating (number)
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.
Timing of Aspiration (category)
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.
Presence of pharyngeal residue (dichotomous)
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.
Extent of hyoid movement (mm)
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.
Upper esophageal sphincter (UES) opening width (mm)
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.

Full Information

First Posted
April 11, 2019
Last Updated
May 8, 2023
Sponsor
University of Wisconsin, Milwaukee
Collaborators
Froedtert Hospital, Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03916809
Brief Title
EMST in Patients Undergoing CRT for HNCA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wisconsin, Milwaukee
Collaborators
Froedtert Hospital, Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Deglutition Disorders
Keywords
oropharyngeal cancer, laryngeal cancer, swallow, chemoradiation, expiratory muscle strength training

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active EMST + Standard Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham EMST + Standard Care
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EMST
Intervention Description
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 Outcome Measure Information:
Title
Feeding-tube-free food intake (days)
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Penetration-Aspiration Scale rating (number)
Description
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.
Time Frame
8 weeks
Title
Timing of Aspiration (category)
Description
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.
Time Frame
8 weeks
Title
Presence of pharyngeal residue (dichotomous)
Description
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.
Time Frame
8 weeks
Title
Extent of hyoid movement (mm)
Description
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.
Time Frame
8 weeks
Title
Upper esophageal sphincter (UES) opening width (mm)
Description
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.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Eating Assessment Tool (EAT-10) (number)
Description
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.
Time Frame
8 weeks
Title
M.D. Anderson Dysphagia Inventory (MDADI) (number)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Pauloski, Ph.D.
Phone
4142296719
Email
pauloski@uwm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Stevens, M.S.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Pauloski
Organizational Affiliation
University of Wisconsin, Milwaukee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Stevens, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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EMST in Patients Undergoing CRT for HNCA

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