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EMST in Patients Undergoing CRT for HNCA

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ClinicalTrials.gov Identifier: NCT03916809
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Froedtert Hospital
Medical College of Wisconsin
Information provided by (Responsible Party):
Barbara Pauloski, University of Wisconsin, Milwaukee

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).

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Deglutition Disorders Other: EMST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes 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.

Primary Purpose: Supportive Care
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)
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active EMST + Standard Care
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
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.

Sham Comparator: Sham EMST + Standard Care
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
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 Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916809


Contacts
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Contact: Barbara Pauloski, Ph.D. 4142296719 pauloski@uwm.edu
Contact: Stephanie Stevens, M.S.

Locations
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United States, Wisconsin
University of Wisconsin Milwaukee Active, not recruiting
Milwaukee, Wisconsin, United States, 53211
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Stephanie Stevens, MS         
Sponsors and Collaborators
University of Wisconsin, Milwaukee
Froedtert Hospital
Medical College of Wisconsin
Investigators
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Principal Investigator: Barbara Pauloski University of Wisconsin, Milwaukee
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Responsible Party: Barbara Pauloski, Associate Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT03916809    
Other Study ID Numbers: PRO29168
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Pauloski, University of Wisconsin, Milwaukee:
oropharyngeal cancer
laryngeal cancer
swallow
chemoradiation
expiratory muscle strength training
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases