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Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer

Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032928
Acronym
RSPT
Enrollment
30
Registered
2009-12-16
Start date
2011-06-30
Completion date
2013-09-30
Last updated
2015-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Cancer, Oropharyngeal Dysphagia

Keywords

Swallowing, Dysphagia, Breathing and swallowing, Oropharyngeal cancer

Brief summary

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.

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

Interventions

Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Optimal Respiratory - Swallow PhasePatient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeksRespiratory 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).

Secondary

MeasureTime frameDescription
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeksAnalysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
Percentage of Impairment According to the Penetration-Aspiration ScalePatient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeksThe 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.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

87 participants were recruited; 67 completed screening; 32 were eligible for enrollment; 2 declined participation

Participants by arm

ArmCount
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.
30
Total30

Baseline characteristics

CharacteristicRespiratory-Swallow Phase Training
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
13 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
Age, Continuous61 years
STANDARD_DEVIATION 11
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
30 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
26 Participants
Region of Enrollment
United States
30 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
26 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

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).

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

ArmMeasureValue (NUMBER)
Pre-interventionOptimal Respiratory - Swallow Phase43 percentage of swallows
One Week Post InterventionOptimal Respiratory - Swallow Phase86 percentage of swallows
One Month Post InterventionOptimal Respiratory - Swallow Phase88.1 percentage of swallows
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

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

ArmMeasureGroupValue (NUMBER)
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngeal stripping wave59.3 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Soft palate elevation19.8 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Bolus transport37.3 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Laryngeal vestibular closure78.2 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)laryngeal elevation76.6 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Tongue control58.7 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Epiglottic inversion71.9 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Anterior hyiod excursion94.7 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngoesophageal segment opening80.6 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Oral residue77.3 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngeal residue96.1 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Lip closure5.7 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Initiation of pharyngeal swallow90.4 percentage of impairment
Pre-interventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Tongue base retraction96.0 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngeal stripping wave67.6 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Lip closure9.3 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Tongue control53.8 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Bolus transport50.2 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Oral residue76.4 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Initiation of pharyngeal swallow90.8 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Soft palate elevation31.0 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)laryngeal elevation70.8 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Anterior hyiod excursion90.5 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Epiglottic inversion68.3 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Laryngeal vestibular closure55.5 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngoesophageal segment opening80.5 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Tongue base retraction88.6 percentage of impairment
One Week Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngeal residue88.4 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Tongue base retraction80.7 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Laryngeal vestibular closure62.2 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Initiation of pharyngeal swallow91.1 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Oral residue71.1 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngeal stripping wave60.7 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Bolus transport41.5 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Lip closure2.8 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngoesophageal segment opening70.0 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Tongue control59.2 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Anterior hyiod excursion93.3 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)laryngeal elevation63.3 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Pharyngeal residue83.0 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Epiglottic inversion55.6 percentage of impairment
One Month Post InterventionPercentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)Soft palate elevation15.6 percentage of impairment
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.

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

ArmMeasureValue (NUMBER)
Pre-interventionPercentage of Impairment According to the Penetration-Aspiration Scale78.0 percentage of swallows with impaired PAS
One Week Post InterventionPercentage of Impairment According to the Penetration-Aspiration Scale38.3 percentage of swallows with impaired PAS
One Month Post InterventionPercentage of Impairment According to the Penetration-Aspiration Scale42.2 percentage of swallows with impaired PAS

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026