DysphagiaNCT02564887
Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
A study testing Iowa Oral Performance Instrument in people with Dysphagia and Oral Pharyngeal Cancer, run by Jonas Johnson at 1 site in United States.
Trial summary
Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Oral Pharyngeal Cancer
- What is being tested?
- Iowa Oral Performance Instrument
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 6 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia.
Who cannot join
- unable to adhere to assigned therapy program due to cognitive deficits
- surgical treatment for head and neck cancer
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise alone to determine if recovery is enhanced and to determine if rate of recovery is accelerated.
- Conditions
- Dysphagia, Oral Pharyngeal Cancer
- Being tested
- Iowa Oral Performance Instrument
- Keywords
- dysphagia, oral pharyngeal cancer, Iowa Oral Performance Instrument (IOPI), IOPI
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iowa Oral Performance InstrumentDevice
Also called IOPI
the IOPI device is being used to increase tongue strength and endurance
| Study group | Role | What they receive |
|---|---|---|
| Traditional Therapy Only | Other | Standard of care therapy for qualifying population (with opportunity to "crossover" and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion. Receives: Device: Iowa Oral Performance Instrument |
| Traditional Therapy with IOPI | Experimental | Standard of care therapy plus the addition of the IOPI instrument Receives: Device: Iowa Oral Performance Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline)
Measured: 8 weeks
Secondary outcomes (5)
Airway Protection During Swallowing
Penetration-aspiration scale score of the modified barium swallow (MBS) data for small, thin liquids Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.
Minimum 1 Maximum 8 Lower is better The score being evaluated is an absolute score at the time of collection and not the change over time.
Measured: 8 week
Change Over Time of Pharyngeal Residue After Swallowing
The change in pharyngeal retention measured using the normalized residue ratio scale (NRR) is being assessed.
The NRR quantifies the amount of residue remaining in the valleculae and pyriform sinuses after a swallow as a ratio of the total area of each of these two pharyngeal spaces.
Value represents the area of space that is occupied by barium at the end of a swallow.
The change from baseline to 8 weeks is documented.
A positive change (+) is worsening of symptoms. A negative change (-) is bettering of symptoms.
Measured: 8 week
Swallowing Impairment-Self Report
Patient perceived outcome measure related to their view of their swallowing problem/difficulties at that point in time.
Eating Assessment Tool (EAT-10). Minimum score 0 Maximum score 40 Higher score is worse Number reported is final overall score
Measured: 8 week
Swallowing Impairment
visual analog scale related to patient perceived swallowing impairment at that point in time.
Minimum - 0 Maximum - 100 Higher is worse Score reported is the overall score at that time and not a change from baseline.
Measured: 8 week
Swallowing Impairment-Objective
functional oral intake scale (FOIS) The Functional Oral Intake Scale is an ordinal scale that is used to assess the current status and meaningful change in the oral intake.
Minimum - 1 Maximum - 7 Higher is better Score reported is the overall score at that point in time and not a change from baseline.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2019
- Study completion6 Sep 2019
Why it stopped: Enrollment goals not met in efficient timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DysphagiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonas Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonas Johnson, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564887
- Sponsor's protocol ID
- PRO15080566
- Status last verified
- Mar 2020
- First submitted
- 28 Sep 2015
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Improve Therapeutic Outcomes for Dysphagia After Radiation Therapy
- ClinicalTrials.gov ID
- NCT02564887
- Acronym / sponsor ID
- PRO15080566
- Conditions
- Dysphagia, Oral Pharyngeal Cancer
- Keywords
- dysphagia, oral pharyngeal cancer, Iowa Oral Performance Instrument (IOPI), IOPI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment goals not met in efficient timeframe.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jonas JohnsonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with head and neck cancer treated with chemoradiation, often develop a treatment associated dysphagia. The common complaint is foods sticking in the pharynx. This study seeks to test the Iowa Oral Performance Instrument (IOPI) in the management of treatment induced dysphagia following chemoradiation for oral, pharyngeal, laryngeal, hypopharyngeal cancer. This pilot study seeks to compare standard exercise therapy plus IOPI to standard exercise alone to determine if recovery is enhanced and to determine if rate of recovery is accelerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Therapy Only | Other | Device: Iowa Oral Performance InstrumentStandard of care therapy for qualifying population (with opportunity to "crossover" and be assigned to the IOPI device if so desired after initial 8 week standard of care therapy completion. |
| Traditional Therapy with IOPI | Experimental | Device: Iowa Oral Performance InstrumentStandard of care therapy plus the addition of the IOPI instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with oral, oropharyngeal, hypopharyngeal or laryngeal cancer having non-surgical treatment with chemoradiation, or radiation therapy alone, resulting in treatment associated dysphagia.
Key exclusion criteria (3 listed)
- unable to adhere to assigned therapy program due to cognitive deficits
- surgical treatment for head and neck cancer
- unable to give informed consent
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 |
|---|---|---|
| Iowa Oral Performance InstrumentAlso: IOPIthe IOPI device is being used to increase tongue strength and endurance | Device | Traditional Therapy Only, Traditional Therapy with IOPI |
Primary outcome
Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device
Time frame: 8 weeks
Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline)
5 secondary outcomes
Airway Protection During Swallowing
Time frame: 8 week
Change Over Time of Pharyngeal Residue After Swallowing
Time frame: 8 week
Swallowing Impairment-Self Report
Time frame: 8 week
Swallowing Impairment
Time frame: 8 week
Swallowing Impairment-Objective
Time frame: 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iowa Oral Performance Instrument in people with Dysphagia and Oral Pharyngeal Cancer, run by Jonas Johnson 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 1 inclusion and 3 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 23 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device (time frame: 8 weeks). 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 23 Mar 2020.