An interventional study of Expiratory Muscle Strength Training and Pharyngeal Muscle Strengthening Exercises in Head and Neck Neoplasms and Deglutition Disorders, sponsored by University of Wisconsin, Milwaukee. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
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 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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 6 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.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions
Behavioral: Expiratory Muscle Strength Training
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 EMST at 75% maximum expiratory pressure (MEP)
8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing
Level of Oral Intake (number)
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).
Time frame: 8 weeks
Maximum Expiratory Pressure (MEP) cm H20
Change in maximum expiratory pressure level will be calculated from baseline 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 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 post-treatment.
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 post-treatment.
Time frame: 8 weeks
Penetration-Aspiration Scale rating (number)
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)
Time frame: 8 weeks
Timing of Aspiration (category)
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.
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 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
Plan to share: No
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This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Milwaukee