An interventional study of EMST in Head and Neck Neoplasms and Deglutition Disorders, sponsored by University of Wisconsin, Milwaukee. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by University of Wisconsin, Milwaukee · Not applicable, Interventional, and Supportive care
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).
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 30 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Wisconsin, Milwaukee is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Eating Assessment Tool (EAT-10) (number)
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
M.D. Anderson Dysphagia Inventory (MDADI) (number)
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
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2017 (actual). Primary completion is estimated for Aug 2025, 96 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 96 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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University of Wisconsin, Milwaukee