Trial Outcomes & Findings for Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer (NCT NCT03377270)
NCT ID: NCT03377270
Last Updated: 2025-05-06
Results Overview
The MBSImP is a standardized outcome measure that evaluates swallowing physiology using 17 distinct component scores across the oral (components 1-6), pharyngeal (components 7-16), and esophageal (component 17) domains. Each component is rated on an ordinal scale based on specific physiologic impairments. Scores range from a minimum of 0 (no impairment) to a maximum of 2, 3, or 4, depending on the component. Higher scores indicate greater swallowing dysfunction, reflecting worse outcomes. For this analysis, the pharyngeal total (PT) score was used as a primary outcome measure. The PT score provides a comprehensive measure of overall pharyngeal function and is a sum of components 7 through 16. The PT Score ranges from 0 to 32, with higher scores indicating greater severity of impairment in pharyngeal swallowing function. A score of 0 represents no impairment, while a score of 32 represents the most severe impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Baseline, 30 days, 60 days, 120 days, 240 days
Results posted on
2025-05-06
Participant Flow
Participant milestones
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
Intervention RST
STARTED
|
28
|
21
|
|
Intervention RST
COMPLETED
|
26
|
15
|
|
Intervention RST
NOT COMPLETED
|
2
|
6
|
|
Follow Up
STARTED
|
26
|
15
|
|
Follow Up
COMPLETED
|
25
|
13
|
|
Follow Up
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=28 Participants
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=21 Participants
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
66 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30 days, 60 days, 120 days, 240 daysPopulation: Of the 49 subjects who entered the intervention phase, 40 were included in the final analysis. Nine participants withdrew.
The MBSImP is a standardized outcome measure that evaluates swallowing physiology using 17 distinct component scores across the oral (components 1-6), pharyngeal (components 7-16), and esophageal (component 17) domains. Each component is rated on an ordinal scale based on specific physiologic impairments. Scores range from a minimum of 0 (no impairment) to a maximum of 2, 3, or 4, depending on the component. Higher scores indicate greater swallowing dysfunction, reflecting worse outcomes. For this analysis, the pharyngeal total (PT) score was used as a primary outcome measure. The PT score provides a comprehensive measure of overall pharyngeal function and is a sum of components 7 through 16. The PT Score ranges from 0 to 32, with higher scores indicating greater severity of impairment in pharyngeal swallowing function. A score of 0 represents no impairment, while a score of 32 represents the most severe impairment.
Outcome measures
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=25 Participants
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=15 Participants
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score
Baseline
|
11.00 score on a scale
Standard Deviation 4.70
|
12.33 score on a scale
Standard Deviation 4.62
|
|
Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score
30 days
|
9.84 score on a scale
Standard Deviation 4.01
|
10.73 score on a scale
Standard Deviation 4.77
|
|
Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score
60 days
|
10.17 score on a scale
Standard Deviation 4.66
|
11.00 score on a scale
Standard Deviation 5.08
|
|
Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score
120 days
|
10.45 score on a scale
Standard Deviation 3.66
|
10.17 score on a scale
Standard Deviation 5.39
|
|
Modified Barium Swallow Impairment Profile (MBSImP) Pharyngeal Total (PT) Score
240 days
|
12.23 score on a scale
Standard Deviation 3.98
|
11.50 score on a scale
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 120 days, 240 daysPopulation: Of the 49 subjects who entered the intervention phase, 40 were included in the final analysis. Nine participants withdrew.
Measures the presence, depth, and reaction to penetration and aspiration during swallowing as observed through videofluoroscopy. The PAS is scored on an 8-point ordinal scale, with values ranging from 1 (no airway entry) to 8 (silent aspiration, with material passing below the vocal folds and no response). Higher scores indicate greater severity of airway compromise, reflecting worse outcomes in terms of swallowing safety.
Outcome measures
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=25 Participants
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=15 Participants
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
Maximum Penetration Aspiration Scale (PAS) Score
Baseline
|
4.16 score on a scale
Standard Deviation 2.44
|
4.73 score on a scale
Standard Deviation 2.58
|
|
Maximum Penetration Aspiration Scale (PAS) Score
30 days
|
3.68 score on a scale
Standard Deviation 2.43
|
3.60 score on a scale
Standard Deviation 1.99
|
|
Maximum Penetration Aspiration Scale (PAS) Score
60 days
|
4.17 score on a scale
Standard Deviation 2.62
|
3.92 score on a scale
Standard Deviation 2.33
|
|
Maximum Penetration Aspiration Scale (PAS) Score
120 days
|
3.77 score on a scale
Standard Deviation 2.58
|
4.67 score on a scale
Standard Deviation 2.19
|
|
Maximum Penetration Aspiration Scale (PAS) Score
240 days
|
4.55 score on a scale
Standard Deviation 2.61
|
4.42 score on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 120 days, 240 daysPopulation: Of the 49 subjects who entered the intervention phase, 40 were included in the final analysis. Nine participants withdrew.
A patient-reported outcome measure designed to assess the impact of dysphagia on quality of life in individuals with head and neck cancer. The MDADI includes 20 items scored across three subscales: Emotional, Functional, and Physical. Each item is rated on a 5-point Likert scale (1 = strongly agree to 5 = strongly disagree), with lower scores indicating worse quality of life related to dysphagia. The Composite Score is calculated by summing the scores from the Emotional, Functional, and Physical subscales. A score of 20 indicates the worst possible quality of life related to dysphagia, while a score of 100 indicates the best possible quality of life.
Outcome measures
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=25 Participants
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=15 Participants
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
MD Anderson Dysphagia Inventory (MDADI) Composite Score
Baseline
|
63.33 score on a scale
Standard Deviation 16.83
|
59.40 score on a scale
Standard Deviation 12.67
|
|
MD Anderson Dysphagia Inventory (MDADI) Composite Score
30 days
|
64.17 score on a scale
Standard Deviation 16.81
|
64.62 score on a scale
Standard Deviation 18.76
|
|
MD Anderson Dysphagia Inventory (MDADI) Composite Score
60 days
|
66.63 score on a scale
Standard Deviation 19.25
|
67.45 score on a scale
Standard Deviation 19.08
|
|
MD Anderson Dysphagia Inventory (MDADI) Composite Score
120 days
|
67.03 score on a scale
Standard Deviation 20.93
|
70.53 score on a scale
Standard Deviation 17.22
|
|
MD Anderson Dysphagia Inventory (MDADI) Composite Score
240 days
|
68.74 score on a scale
Standard Deviation 17.49
|
71.49 score on a scale
Standard Deviation 18.81
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 120 days, 240 daysPopulation: Of the 49 subjects who entered the intervention phase, 40 were included in the final analysis. Nine participants withdrew.
Assesses the level of oral intake in individuals with dysphagia. The FOIS is scored on a 7-point ordinal scale, ranging from 1 (nothing by mouth) to 7 (full oral intake with no restrictions). Higher scores indicate better functional oral intake and less dependence on alternative feeding methods.
Outcome measures
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=25 Participants
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=15 Participants
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
Functional Oral Intake Scale (FOIS) Score
Baseline
|
5.56 score on a scale
Standard Deviation 1.19
|
5.43 score on a scale
Standard Deviation 0.94
|
|
Functional Oral Intake Scale (FOIS) Score
30 days
|
5.56 score on a scale
Standard Deviation 1.16
|
5.67 score on a scale
Standard Deviation 1.23
|
|
Functional Oral Intake Scale (FOIS) Score
60 days
|
5.64 score on a scale
Standard Deviation 0.95
|
5.64 score on a scale
Standard Deviation 1.12
|
|
Functional Oral Intake Scale (FOIS) Score
120 days
|
5.68 score on a scale
Standard Deviation 0.95
|
5.83 score on a scale
Standard Deviation 1.11
|
|
Functional Oral Intake Scale (FOIS) Score
240 days
|
5.86 score on a scale
Standard Deviation 1.31
|
6.09 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 60 days, 120 days, 240 daysPopulation: Of the 49 subjects who entered the intervention phase, 40 were included in the final analysis. Nine participants withdrew.
Evaluates the functional impact of head and neck cancer on patients' ability to eat and communicate. The PSS-HN includes three subscales: Normalcy of Diet, Understandability of Speech, and Eating in Public, each scored on a 0-100 scale, with higher scores indicating better performance and less functional impairment.
Outcome measures
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=25 Participants
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=15 Participants
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
Baseline PSS-HN Diet
|
59.60 score on a scale
Standard Deviation 21.31
|
60.77 score on a scale
Standard Deviation 21.39
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
30 days PSS-HN Diet
|
60.50 score on a scale
Standard Deviation 20.64
|
67.27 score on a scale
Standard Deviation 24.53
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
60 days PSS-HN Diet
|
60.00 score on a scale
Standard Deviation 20.29
|
61.11 score on a scale
Standard Deviation 22.05
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
120 days PSS-HN Diet
|
63.75 score on a scale
Standard Deviation 20.29
|
68.00 score on a scale
Standard Deviation 23.00
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
240 days PSS-HN Diet
|
69.52 score on a scale
Standard Deviation 22.02
|
78.00 score on a scale
Standard Deviation 22.51
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
Baseline PSS-HN Public
|
73.96 score on a scale
Standard Deviation 32.54
|
85.42 score on a scale
Standard Deviation 22.51
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
30 days PSS-HN Public
|
73.75 score on a scale
Standard Deviation 31.91
|
81.82 score on a scale
Standard Deviation 27.59
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
60 days PSS-HN Public
|
77.94 score on a scale
Standard Deviation 23.19
|
72.22 score on a scale
Standard Deviation 34.11
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
120 days PSS-HN Public
|
76.56 score on a scale
Standard Deviation 28.09
|
82.50 score on a scale
Standard Deviation 31.29
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
240 days PSS-HN Public
|
76.19 score on a scale
Standard Deviation 29.02
|
90.91 score on a scale
Standard Deviation 20.23
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
Baseline PSS-HN Speech
|
92.71 score on a scale
Standard Deviation 13.75
|
85.42 score on a scale
Standard Deviation 12.87
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
30 days PSS-HN Speech
|
90.00 score on a scale
Standard Deviation 17.01
|
90.91 score on a scale
Standard Deviation 12.61
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
60 days PSS-HN Speech
|
89.71 score on a scale
Standard Deviation 17.81
|
93.75 score on a scale
Standard Deviation 11.57
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
120 days PSS-HN Speech
|
92.19 score on a scale
Standard Deviation 15.05
|
85.00 score on a scale
Standard Deviation 21.08
|
|
Performance Status Scale for Head and Neck Cancer (PSS-HN) Subscales Scores
240 days PSS-HN Speech
|
92.86 score on a scale
Standard Deviation 14.02
|
88.64 score on a scale
Standard Deviation 13.06
|
Adverse Events
Arm 1. Immediate Respiratory-Swallow Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2. Delayed Respiratory-Swallow Training
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1. Immediate Respiratory-Swallow Training
n=28 participants at risk
Description: Participants receive Respiratory-Swallow Training (RST) immediately after baseline evaluation. RST retrains swallowing initiation to occur during exhalation at mid-to-low lung volumes.
Intervention Schedule: Begins within 1 week of baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
Arm 2. Delayed Respiratory-Swallow Training
n=21 participants at risk
Description: Participants receive no active intervention for the first 4 weeks post-baseline, then begin Respiratory-Swallow Training (RST) using the same protocol as Arm 1.
Intervention Schedule: Begins 4 weeks after baseline evaluation and continues for 4 weeks (two 1-hour sessions per week).
Post-RST Assessment: Conducted within 1-week post-intervention and at 1-, 3-, and 6-months to assess efficacy and durability.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular Accident (CVA)
|
0.00%
0/28 • 240 days
This two-arm RCT was designed to assess the timing of Respiratory-Swallow Training (RST) on swallowing outcomes. All participants received RST; the only difference was when it began. Arm 1 received RST immediately; Arm 2 after a 4-week delay reflecting standard care in patients with chronic dysphagia post-HNC. Adverse events are attributed by assigned arm. Adding a third "no-treatment" arm would inaccurately suggest a subgroup of participants who received no intervention at all.
|
4.8%
1/21 • Number of events 1 • 240 days
This two-arm RCT was designed to assess the timing of Respiratory-Swallow Training (RST) on swallowing outcomes. All participants received RST; the only difference was when it began. Arm 1 received RST immediately; Arm 2 after a 4-week delay reflecting standard care in patients with chronic dysphagia post-HNC. Adverse events are attributed by assigned arm. Adding a third "no-treatment" arm would inaccurately suggest a subgroup of participants who received no intervention at all.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place