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EMST and Swallowing in Long-Term Survivors of HNCA

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ClinicalTrials.gov Identifier: NCT03975465
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 6, 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 oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Deglutition Disorders Behavioral: Expiratory Muscle Strength Training Behavioral: Pharyngeal Muscle Strengthening Exercises Not Applicable

Detailed Description:

Twenty (20) persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously will be randomized to an 8-week program of either EMST only and Standard Care only in order to examine the impact of EMST on swallowing function. The EMST program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. Patients randomized to the EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Standard Care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. Subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks.

All subjects will be evaluated at baseline and at the completion of their rehabilitation program. Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, administration of swallow-related quality of life (QOL) questionnaires, and documentation of current diet using the International Dysphagia Diet Standardisation Initiative (IDDSI) Drink Levels and Food Levels.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to an 8-week program of either Expiratory Muscle Strength Training (EMST) or Standard Care in order to examine the impact of EMST on swallowing function
Masking: Single (Outcomes Assessor)
Masking Description: Researchers assessing the outcomes will not know the arm to which the subject was randomized.
Primary Purpose: Supportive Care
Official Title: Effects of Expiratory Muscle Strength Training (EMST) on Long-Term Swallowing Dysfunction in Persons With Head and Neck Cancer (HNCA) Post Irradiation (RT)
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Expiratory Muscle Strength Training
Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions
Behavioral: Expiratory Muscle Strength Training
8 weeks of EMST at 75% maximum expiratory pressure (MEP)

Active Comparator: Pharyngeal Muscle Strengthening Exercises
Patients randomized to Standard Care will receive swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion
Behavioral: Pharyngeal Muscle Strengthening Exercises
8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing




Primary Outcome Measures :
  1. Level of Oral Intake (number) [ Time Frame: 8 weeks ]

    Change in Food Level and Drink Level on International Dysphagia Diet Standardisation Initiative (IDDSI) scale will be calculated from baseline to post-treatment.

    IDDSI scale rates the level of liquid or food that the person can eat. Scale values range from 0 to 7, with higher values indicating better outcome (greater ability to eat).


  2. Maximum Expiratory Pressure (MEP) cm H20 [ Time Frame: 8 weeks ]
    Change in maximum expiratory pressure level will be calculated from baseline to post-treatment.

  3. 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 post-treatment.

  4. 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 post-treatment.

  5. 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 post-treatment.

  6. Penetration-Aspiration Scale rating (number) [ Time Frame: 8 weeks ]
    From Videofluoroscopic Swallow Studies (VFSS), change in the Penetration-Aspiration Scale (PAS) score will be determined from baseline to post-treatment. Penetration-Aspiration Scale is an 8-point ordinal rating scale that rates the depth to which food or liquid invades the airway. Values range from a minimum of 1 to a maximum of 8; higher values represent worse outcome (i.e. greater depth of invasion into the airway)

  7. Timing of Aspiration (category) [ Time Frame: 8 weeks ]
    From Videofluoroscopic Swallow Studies (VFSS), timing of aspiration will be determined from baseline to post-treatment. Timing is identified as a category, either before, during, or after.


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 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:

  1. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. Subjects may have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment;
  2. Subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies;
  3. Ability to follow directions and engage in a program of rehabilitation

Exclusion Criteria:

  1. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
  2. the subject presents with contraindications for EMST as specified in the EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.

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): NCT03975465


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, Ph.D. University of Wisconsin, Milwaukee

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Responsible Party: Barbara Pauloski, Associate Professor, University of Wisconsin, Milwaukee
ClinicalTrials.gov Identifier: NCT03975465     History of Changes
Other Study ID Numbers: PRO32538
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 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
long-term survivor

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