Trial Outcomes & Findings for Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer (NCT NCT04952922)
NCT ID: NCT04952922
Last Updated: 2025-08-08
Results Overview
Performance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head \& neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores
COMPLETED
25 participants
Baseline, 3 months, 6 months
2025-08-08
Participant Flow
Difficulties recruiting participants to the study, number recruited will be adequate for analysis and will meet criteria for primary endpoint
Participant milestones
| Measure |
Group 1
Patients with a diagnosis of recurrent oropharyngeal cancer - prospective
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Group 1
n=25 Participants
Patients with a diagnosis of recurrent oropharyngeal cancer - prospective
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
|
Age, Continuous
|
64 YEARS
n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPerformance Scale for Head and Neck Cancer (PSS-HN) Normalcy of Diet (NoD) scores Three subscales: Normalcy of Diet, Understandability of Speech, Eating in Public Scores are combined to describe patient function in 6 areas (physical well-being, social and family well-being, relationship with doctor, emotional well-being, functional well-being, head \& neck related symptoms) Total score Scale 0 -100, a higher score indicating better performance/higher quality of life The score reported is the combined score with the total being the sum of the sub-scale scores
Outcome measures
| Measure |
Group 1
n=25 Participants
Patients with a diagnosis of recurrent oropharyngeal cancer - prospective
|
|---|---|
|
Patient Reported Swallowing Related Quality of Life
Baseline
|
50 score on a scale
Interval 0.0 to 100.0
|
|
Patient Reported Swallowing Related Quality of Life
3 months
|
40 score on a scale
Interval 0.0 to 100.0
|
|
Patient Reported Swallowing Related Quality of Life
6 months
|
40 score on a scale
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Some participants were unable to complete/did not wish to complete the water swallow test
The Water Swallow Test is used to monitor swallow performance and possible aspiration - patients are viewed to have failed the test if they cough, have a wet voice quality post swallow or are unable to complete the task.
Outcome measures
| Measure |
Group 1
n=17 Participants
Patients with a diagnosis of recurrent oropharyngeal cancer - prospective
|
|---|---|
|
Swallowing Status Measured Using the 100ml Water Swallow Test
Baseline
|
9.7 ml/second
Interval 6.2 to 16.3
|
|
Swallowing Status Measured Using the 100ml Water Swallow Test
3 months
|
16.6 ml/second
Interval 13.3 to 33.2
|
|
Swallowing Status Measured Using the 100ml Water Swallow Test
6 months
|
17.9 ml/second
Interval 12.0 to 33.1
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Not all participants completed the questionnaire
The scale consists of 8 levels (0-7) where drinks are measured as 0-4 to describe thickness (0 being thin, 4 being extremely thick) and foods are measured as 3-7 (3 being liquidised, 7 being regular/easy to chew) A higher score indicates a higher level of swallowing function, 0 being the lowest score, 7 being the highest score
Outcome measures
| Measure |
Group 1
n=25 Participants
Patients with a diagnosis of recurrent oropharyngeal cancer - prospective
|
|---|---|
|
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
Baseline
|
7 score on a scale
Interval 0.0 to 7.0
|
|
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
3 months
|
6 score on a scale
Interval 0.0 to 7.0
|
|
Swallowing Status Measured With the Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
6 months
|
6 score on a scale
Interval 0.0 to 7.0
|
Adverse Events
Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Grainne Brady
The Royal Marsden NHS Foundation Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place