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| ID | Type | Description | Link |
|---|---|---|---|
| RX000152-01A1 | Registry Identifier | Dept of Veterans Affairs, ORD |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory Phase Training | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory-Swallow Phase training | Behavioral | Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optimal Respiratory - Swallow Phase | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP) | Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie J Martin-Harris | Ralph H Johnson VA Medical Center, Charleston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H Johnson VA Medical Center, Charleston | Charleston | South Carolina | 29401-5799 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25498307 | Derived | Martin-Harris B, McFarland D, Hill EG, Strange CB, Focht KL, Wan Z, Blair J, McGrattan K. Respiratory-swallow training in patients with head and neck cancer. Arch Phys Med Rehabil. 2015 May;96(5):885-93. doi: 10.1016/j.apmr.2014.11.022. Epub 2014 Dec 11. |
| Label | URL |
|---|---|
| Click here for more information about this study: Respiratory-Swallow Training in Veterans with Oropharyngeal Cancer | View source |
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87 participants were recruited; 67 completed screening; 32 were eligible for enrollment; 2 declined participation
Participants were recruited from the Head and Neck Clinics at the Ralph H Johnson Veterans Administration Medical Center and the Medical University of South Carolina between May 2010 and April 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Respiratory - Swallow Phase Training | Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Entire Enrolled Study Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Respiratory-Swallow Phase Training | Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP) | Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system | Posted | Number | percentage of impairment | Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks |
|
Duration of the study
Patient completed daily EXACT-PRO questionnaires regarding respiratory symptoms. Reported changes were reviewed by pulmonologist
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bonnie Martin Harris | Ralph H Johnson VA Medical Center | 843-792-0879 | Bonnie.Martin-Harris@va.gov |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D009959 | Oropharyngeal Neoplasms |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Percentage of Impairment According to the Penetration-Aspiration Scale |
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 |
| National website for dysphagia research | View source |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| One Month Post Intervention |
VAMC participants were assessed at one month following completion of the treatment protocol |
|
|
| Secondary | Percentage of Impairment According to the Penetration-Aspiration Scale | 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. | Posted | Number | percentage of swallows with impaired PAS | Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks |
|
|
|
| Primary | Optimal Respiratory - Swallow Phase | 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). | Posted | Number | percentage of swallows | 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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|
|
| 0 |
| 30 |
| 0 |
| 30 |
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| D010038 | Otorhinolaryngologic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009057 | Stomatognathic Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |