Trial Outcomes & Findings for Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer (NCT NCT01032928)
NCT ID: NCT01032928
Last Updated: 2015-01-01
Results Overview
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).
COMPLETED
PHASE2
30 participants
Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
2015-01-01
Participant Flow
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
87 participants were recruited; 67 completed screening; 32 were eligible for enrollment; 2 declined participation
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Respiratory-Swallow Phase Training
n=30 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Patient 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).
Outcome measures
| Measure |
Pre-intervention
n=30 Participants
Subjects eligible for enrollment
|
One Week Post Intervention
n=30 Participants
Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
|
One Month Post Intervention
n=15 Participants
VAMC participants were assessed at one month following completion of the treatment protocol
|
|---|---|---|---|
|
Optimal Respiratory - Swallow Phase
|
43 percentage of swallows
|
86 percentage of swallows
|
88.1 percentage of swallows
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pre-intervention
n=30 Participants
Subjects eligible for enrollment
|
One Week Post Intervention
n=30 Participants
Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
|
One Month Post Intervention
n=15 Participants
VAMC participants were assessed at one month following completion of the treatment protocol
|
|---|---|---|---|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Laryngeal vestibular closure
|
78.2 percentage of impairment
|
55.5 percentage of impairment
|
62.2 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Lip closure
|
5.7 percentage of impairment
|
9.3 percentage of impairment
|
2.8 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Tongue control
|
58.7 percentage of impairment
|
53.8 percentage of impairment
|
59.2 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Bolus transport
|
37.3 percentage of impairment
|
50.2 percentage of impairment
|
41.5 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Oral residue
|
77.3 percentage of impairment
|
76.4 percentage of impairment
|
71.1 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Initiation of pharyngeal swallow
|
90.4 percentage of impairment
|
90.8 percentage of impairment
|
91.1 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Soft palate elevation
|
19.8 percentage of impairment
|
31.0 percentage of impairment
|
15.6 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
laryngeal elevation
|
76.6 percentage of impairment
|
70.8 percentage of impairment
|
63.3 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Anterior hyiod excursion
|
94.7 percentage of impairment
|
90.5 percentage of impairment
|
93.3 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Epiglottic inversion
|
71.9 percentage of impairment
|
68.3 percentage of impairment
|
55.6 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Pharyngeal stripping wave
|
59.3 percentage of impairment
|
67.6 percentage of impairment
|
60.7 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Pharyngoesophageal segment opening
|
80.6 percentage of impairment
|
80.5 percentage of impairment
|
70.0 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Tongue base retraction
|
96.0 percentage of impairment
|
88.6 percentage of impairment
|
80.7 percentage of impairment
|
|
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Pharyngeal residue
|
96.1 percentage of impairment
|
88.4 percentage of impairment
|
83.0 percentage of impairment
|
SECONDARY outcome
Timeframe: Patient 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.
Outcome measures
| Measure |
Pre-intervention
n=30 Participants
Subjects eligible for enrollment
|
One Week Post Intervention
n=30 Participants
Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
|
One Month Post Intervention
n=15 Participants
VAMC participants were assessed at one month following completion of the treatment protocol
|
|---|---|---|---|
|
Percentage of Impairment According to the Penetration-Aspiration Scale
|
78.0 percentage of swallows with impaired PAS
|
38.3 percentage of swallows with impaired PAS
|
42.2 percentage of swallows with impaired PAS
|
Adverse Events
Arm 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bonnie Martin Harris
Ralph H Johnson VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place