Malignant Head and Neck NeoplasmNCT03175289
Expiratory Muscle Strength Training in Improving Bulbar Function and Quality of Life in Patients With Head and Neck Cancer
A study testing Best Practice, Educational Intervention and Exercise Intervention in people with Malignant Head and Neck Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing… Read more about this study
- Who is it for?
- Ages 19 to 78 years
- Conditions the study is for
- Malignant Head and Neck Neoplasm
- What is being tested?
- Best Practice, Educational Intervention and Exercise Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2016to 3 Jan 2019
- 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 19 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a definitive, curative treatment plan consisting of chemoradiation for head \& neck cancer
- Surgery, if required, must be limited to: diagnostic biopsy
Who cannot join
- Participants enrolled in a radiation de-intensification protocol
- Current or previous neurological disease, which may adversely affect swallowing
- History of oropharyngeal swallowing disorder prior to cancer diagnosis
- Previous neurosurgery on the brain
- Severe chronic obstructive pulmonary disease (COPD) requiring oxygen dependence, as this is a contraindication of EMST
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer
This randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing, airway safety, swallow function, and quality of life in patients with head and neck cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Investigate the impact of a prophylactic targeted exercise program, expiratory muscle strength training (EMST), on swallowing function and well-being of individuals on head and neck cancer (HNC).
II. Determine the impact of EMST on objective respiratory measures of individuals with HNC.
III. Determine the relationship between mean dose across the swallowing muscles (oral tongue and supra-hyoids, base of tongue, superior, middle and inferior pharyngeal constrictors, proximal esophagus)/dose on each muscle and the swallowing functional outcomes from aim 1.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions.
ARM II: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy.
After completion of study, patients are followed up at 1, 3, 6, and 12 months.
- Conditions
- Malignant Head and Neck Neoplasm
- Being tested
- Best Practice, Educational Intervention, Exercise Intervention, Expiratory Muscle Strength Training, Quality-of-Life Assessment
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Undergo therapy session conducted by a speech pathologist
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
Exercise InterventionOther
Perform prescribed home exercises
Expiratory Muscle Strength TrainingOther
Also called EMST
Participate in EMST
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care, home exercises) | Active comparator | Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions. Receives: Other: Best Practice; Other: Educational Intervention; Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (standard of care, home exercises, EMST) | Experimental | Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy Receives: Other: Best Practice; Other: Educational Intervention; Other: Exercise Intervention; Other: Expiratory Muscle Strength Training; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway safety during swallowing assessed using the Penetration-Aspiration Scale
Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
Measured: Up to 1 year
Secondary outcomes (9)
Eating Assessment Tool-10
Collected variables will be estimated through patient and clinician surveys.
Measured: Up to 1 year
Expiratory flow assessed using portable digital peak flow meter
Exploratory mixed effect model will be used to investigate respiratory measures with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
Measured: Up to 1 year
Functional Oral Intake Scale (FOIS)
Collected variables will be estimated through patient and clinician surveys.
Measured: Up to 1 year
Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument
Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
Measured: Up to 1 year
Maximum expiratory pressure assessed using the MicroRPM pressure meter
Exploratory mixed effect model will be used to investigate respiratory measures with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
Measured: Up to 1 year
Maximum mandibular opening using the TheraBite range of motion scale
Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
Measured: Up to 1 year
Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Exploratory mixed effect model will be used to investigate quality of life with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable.
Measured: Up to 1 year
Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study
Logistic regression method will be used to explore associations between treatment and respiratory-swallow phase (normal/abnormal).
Measured: Up to 1 year
Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile
Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start29 Sep 2016
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Head and Neck NeoplasmStudies 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
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loni Arrese, PhD, SLP, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175289
- Sponsor's protocol ID
- OSU-16023
- Other IDs
- NCI-2017-00848
- Status last verified
- May 2019
- First submitted
- 1 Jun 2017
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Expiratory Muscle Strength Training on Bulbar Function and Well Being of Individuals With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03175289
- Acronym / sponsor ID
- OSU-16023
- Conditions
- Malignant Head and Neck Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 5 Jun 2017 (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 randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing, airway safety, swallow function, and quality of life in patients with head and neck cancer.
Detailed description
PRIMARY OBJECTIVES:
- Investigate the impact of a prophylactic targeted exercise program, expiratory muscle strength training (EMST), on swallowing function and well-being of individuals on head and neck cancer (HNC).
II. Determine the impact of EMST on objective respiratory measures of individuals with HNC.
III. Determine the relationship between mean dose across the swallowing muscles (oral tongue and supra-hyoids, base of tongue, superior, middle and inferior pharyngeal constrictors, proximal esophagus)/dose on each muscle and the swallowing functional outcomes from aim 1.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions.
ARM II: Patients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy.
After completion of study, patients are followed up at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care, home exercises) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients also perform prescribed exercises at home daily for 3 sets of 10 repetitions. |
| Arm II (standard of care, home exercises, EMST) | Experimental | Other: Best Practice, Other: Educational Intervention, Other: Exercise Intervention, Other: Expiratory Muscle Strength Training, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care comprising of written patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus. Patients participate in a therapy session conducted by a speech pathologist over 30 minutes once per week for 6 weeks during chemoradiation therapy. Patients perform prescribed exercises at home daily for 3 sets of 10 repetitions. Patients also participate in an EMST session over 30 minutes comprising of 5 sets of 5 repetitions daily for 5 days per week for 6 weeks during chemoradiation therapy |
Who may qualify
- Ages
- 19 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a definitive, curative treatment plan consisting of chemoradiation for head \& neck cancer
Key exclusion criteria (5 listed)
- Participants enrolled in a radiation de-intensification protocol
- Current or previous neurological disease, which may adversely affect swallowing
- History of oropharyngeal swallowing disorder prior to cancer diagnosis
- Previous neurosurgery on the brain
- Severe chronic obstructive pulmonary disease (COPD) requiring oxygen dependence, as this is a contraindication of EMST
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyUndergo therapy session conducted by a speech pathologist | Other | Arm I (standard of care, home exercises), Arm II (standard of care, home exercises, EMST) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus | Other | Arm I (standard of care, home exercises), Arm II (standard of care, home exercises, EMST) |
| Exercise InterventionPerform prescribed home exercises | Other | Arm I (standard of care, home exercises), Arm II (standard of care, home exercises, EMST) |
| Expiratory Muscle Strength TrainingAlso: EMSTParticipate in EMST | Other | Arm II (standard of care, home exercises, EMST) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (standard of care, home exercises), Arm II (standard of care, home exercises, EMST) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard of care, home exercises), Arm II (standard of care, home exercises, EMST) |
Primary outcome
Airway safety during swallowing assessed using the Penetration-Aspiration Scale
Time frame: Up to 1 year
Exploratory mixed effect model will be used to investigate swallow function with time (pre and 1, 3, 6, and 12 month post) as the within-subjects variable and group (expiratory muscle strength training and control) as the between-subjects variable. Pearson or Spearman correlation methods will be used to evaluate the relationship between swallow function/patterning and respiratory and swallow safety measures.
9 secondary outcomes
Eating Assessment Tool-10
Time frame: Up to 1 year
Expiratory flow assessed using portable digital peak flow meter
Time frame: Up to 1 year
Functional Oral Intake Scale (FOIS)
Time frame: Up to 1 year
Lingual strength defined as the maximum pressure of the tongue pressing against the hard palate measured using the Iowa Oral Performance Instrument
Time frame: Up to 1 year
Maximum expiratory pressure assessed using the MicroRPM pressure meter
Time frame: Up to 1 year
Maximum mandibular opening using the TheraBite range of motion scale
Time frame: Up to 1 year
Patient reported quality of life assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: Up to 1 year
Respiratory-swallow phase patterns captured using the standard Modified Barium Swallow Study
Time frame: Up to 1 year
Swallow pathophysiology assessed using the Modified Barium Swallow Impairment Profile
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- The JameslineLink provided by the sponsor.
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Head and Neck Cancer
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.
Loni Arrese, PhD, SLP principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Educational Intervention and Exercise Intervention in people with Malignant Head and Neck Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Airway safety during swallowing assessed using the Penetration-Aspiration Scale (time frame: Up to 1 year). 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 21 May 2019.