Head and Neck NeoplasmsNCT03975465
EMST and Swallowing in Long-Term Survivors of HNCA
A study testing Expiratory Muscle Strength Training and Pharyngeal Muscle Strengthening Exercises in people with Head and Neck Neoplasms and Deglutition Disorders, run by University of Wisconsin, Milwaukee at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Deglutition Disorders
- What is being tested?
- Expiratory Muscle Strength Training and Pharyngeal Muscle Strengthening Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2018to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
- Ability to follow directions and engage in a program of rehabilitation
Who cannot join
- the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Milwaukee
Milwaukee, Wisconsin, 53211
Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
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)
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.
Read the 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.
- Conditions
- Head and Neck Neoplasms, Deglutition Disorders
- Being tested
- Expiratory Muscle Strength Training, Pharyngeal Muscle Strengthening Exercises
- Keywords
- oropharyngeal cancer, laryngeal cancer, swallow, chemoradiation, expiratory muscle strength training, long-term survivor
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders, Oropharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Muscle Strength TrainingBehavioural
8 weeks of EMST at 75% maximum expiratory pressure (MEP)
Pharyngeal Muscle Strengthening ExercisesBehavioural
8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Muscle Strength Training | Experimental | Patients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions Receives: Behavioral: Expiratory Muscle Strength Training |
| Pharyngeal Muscle Strengthening Exercises | Active comparator | 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 Receives: Behavioral: Pharyngeal Muscle Strengthening Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Maximum Expiratory Pressure (MEP) cm H20
Change in maximum expiratory pressure level will be calculated from baseline to post-treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start10 Sep 2018
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Why it stopped: Poor accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- Froedtert Hospital, Medical College of Wisconsin
- Responsible party
- Principal investigator, Barbara Pauloski, University of Wisconsin, Milwaukee
- Investigators
- Barbara Pauloski, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975465
- Sponsor's protocol ID
- PRO32538
- Status last verified
- Dec 2024
- First submitted
- 1 Jun 2019
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03975465
- Acronym / sponsor ID
- PRO32538
- Conditions
- Head and Neck Neoplasms, Deglutition Disorders
- Keywords
- oropharyngeal cancer, laryngeal cancer, swallow, chemoradiation, expiratory muscle strength training, long-term survivor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accruals
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- Froedtert Hospital, Medical College of Wisconsin
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Strength Training | Experimental | Behavioral: Expiratory Muscle Strength TrainingPatients randomized to the EMST arm will use the EMST150 device as packaged, i.e. following package instructions |
| Pharyngeal Muscle Strengthening Exercises | Active comparator | Behavioral: Pharyngeal Muscle Strengthening ExercisesPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
- 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;
- Ability to follow directions and engage in a program of rehabilitation
Key exclusion criteria (2 listed)
- the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory Muscle Strength Training8 weeks of EMST at 75% maximum expiratory pressure (MEP) | Behavioural | Expiratory Muscle Strength Training |
| Pharyngeal Muscle Strengthening Exercises8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing | Behavioural | Pharyngeal Muscle Strengthening Exercises |
Primary outcome
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).
Maximum Expiratory Pressure (MEP) cm H20
Time frame: 8 weeks
Change in maximum expiratory pressure level will be calculated from baseline to post-treatment.
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.
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.
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.
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)
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.
Results and safety
The study was stopped early (reason given: Poor accruals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Pauloski, Ph.D. principal investigator
University of Wisconsin, Milwaukee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Muscle Strength Training and Pharyngeal Muscle Strengthening Exercises in people with Head and Neck Neoplasms and Deglutition Disorders, run by University of Wisconsin, Milwaukee at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor accruals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Oral Intake (number) (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.