EMST in Patients Undergoing CRT for HNCA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Milwaukee
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
EMST
Other interventionExpiratory 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active EMST + Standard CareExperimental treatment 1 intervention
Group B: Sham EMST + Standard CareSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
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 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Milwaukee
Lead sponsor
Froedtert Hospital
Collaborator
Medical College of Wisconsin
Collaborator
Source ClinicalTrials.gov