- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032928
Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer (RSPT)
December 9, 2014 updated by: US Department of Veterans Affairs
Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that are intended to cure the disease.
These treatments have toxic effects on muscles and structures that are necessary to swallow safely and efficiently.
The resulting swallowing problems (dysphagia) often remain chronic for Veterans and interfere with their ability to eat and drink.
The cost burden to the VA health system is high.
There is an urgent need to develop rehabilitative treatments that lessen these burdens.
The proposed research is designed to test a novel swallowing therapy that includes the coordination of breathing with swallowing.
Our study will train medically and surgically treated, chronically dysphagic Veterans with histories of oropharyngeal cancer in a novel therapy that involves both swallowing and respiratory systems.
If the therapy is found to be effective, the long term goal of the project is to extend the study to a multi-site, clinical trial and test the longstanding effect of this treatment compared to other swallowing therapies on swallowing function, QOL and cost.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Swallowing impairments (dysphagia) represent the highest functional morbidity in veteran patients treated for oropharyngeal cancers with either surgical approaches followed by radiation or with more recent organ-preservation protocols.
The nature of the impairments is often resistive to treatment and results in life-long health consequences and high cost burden on the VA health system.
Recent preliminary data have linked alterations in the otherwise highly stable respiratory-swallowing phase pattern relationships to the swallowing impairment and penetration/aspiration and in this patient group.
The immediate goal of this clinical trial is to test the effect of a novel respiratory-swallow intervention on swallowing impairment and penetration/aspiration in a cohort of chronically dysphagic veterans following treatment for oropharyngeal cancer.
Patients presenting with a "non-optimal" respiratory-swallow phase pattern during liquid swallows and measurable swallowing impairment will learn an "optimal" physiologic pattern that facilitates both airway protective and mechanical advantages during swallowing.
The broad goal of this research is to develop ideal respiratory-swallowing phase training methods and regimens that alone or combined with traditional swallowing treatments improve swallowing function in the acute phases of recovery and improve long term patient outcome.
Our intention is to use these preliminary data to motivate a larger clinical trial to compare the effect of respiratory-swallow phase training with other evidenced based methods of swallowing treatment and expand the approach to other patient groups that have indications of respiratory-swallow phase impairments (e.g.
pulmonary disease and stroke) contributing to impaired swallowing function
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Ralph H Johnson VA Medical Center, Charleston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- at least 21 years of age
- agreed to participate in this study and signed an informed consent, either completed by the participant or designated other
- have chronic impairments in oropharyngeal swallowing function following chemotherapy, radiation, and/or surgical intervention for the treatment of first time diagnosis of squamous cell carcinoma of the head and neck
- have completed medical treatments for his/her cancer and any traditional swallowing therapy at least 6 months earlier
- pass a cognitive screening (COGNISTAT)
- have at least one area of impairment (initiation of pharyngeal swallow, anterior hyolaryngeal excursion, extent and duration of PES opening, tongue base retraction, pharyngeal residue) as indicated by the results of the pre-intervention MBSImP (total sum MBSImP
- have PAS scores >/= 3 on 10% of swallows on pre-intervention MBSS
- have a non-optimal (E-I, I-E, or I-I) breathing pattern on 60% of trial swallows.
Exclusion Criteria:
- known allergy or dietary restriction for food or contrast materials used during the exam
- evidence of persistent or recurrent disease on physical examination of the head and neck
- evidence of esophageal stricture noted on MBS
- recurrent oropharyngeal cancer and/or are being treated for other cancer(s) concurrently
- severe COPD (see Pulmonary Criteria below)
- nasogastric feeding tube
- recent change in swallowing status characterized by increase in perceived or observed -swallowing problems by patient, family or testing SLP
- any co-occurring neurological impairment affecting muscle strength and/or cognition
- history of aspiration pneumonia over the past 12 months.
- fail cognitive screening
- absence of swallowing impairment
- evidence of esophageal stricture on MBS
- inability to tolerate at least one of the liquid barium consistencies
- consistent optimal respiratory-swallow phase patterning
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Respiratory Phase Training
Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns participated in up to 8 sessions of respiratory phase training to learn an optimal respiratory - swallow phase pattern
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Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal Respiratory - Swallow Phase
Time Frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
|
Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study.
The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab.
Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).
|
Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Time Frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
|
Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
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Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
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Percentage of Impairment According to the Penetration-Aspiration Scale
Time Frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
|
The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events.
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.
Scores < 3 are considered to be normal.
For the purpose of our study scores were dichotimized to normal and impaired.
|
Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bonnie J Martin-Harris, Ralph H Johnson VA Medical Center, Charleston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
September 1, 2013
Study Registration Dates
First Submitted
December 14, 2009
First Submitted That Met QC Criteria
December 14, 2009
First Posted (ESTIMATE)
December 16, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 1, 2015
Last Update Submitted That Met QC Criteria
December 9, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C7135-R
- RX000152-01A1 (REGISTRY: Dept of Veterans Affairs, ORD)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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