TriangleNCT02123511 · OUTCOME
EORTC Quality of Life Questionnaire (QLQ) Swallowing
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 90 days after completion of radiation therapy
What was measured
Average Area Under the Curve per assessment (aAUCpa) of QLQ H\&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, \& weight gain. The QLQ H\&N35 scoring algorithm was used for swallowing (questions 35-38) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient \& subscale, the subscale values at treatment-initiation \& assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.
Analysis population: Patients who completed the QLQ H\&N Swallowing at all specified time points are included in this analysis.
Groups in this outcome
Arm A (Placebo)
Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
Arm B (Rincinol)
Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
| Group | Source count |
|---|---|
| Arm A (Placebo) | 10 |
| Arm B (Rincinol) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Placebo) | 34.7 | 18.8 | Not reported | Not reported | Not reported |
| Arm B (Rincinol) | 22.3 | 17.6 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- statistical Method
- t-test, 1 sided
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.17
- statistical Method
- t-test, 1 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.8
- value
- 34.7
- group Id
- OG001
- spread
- 17.6
- value
- 22.3
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- Average Area Under the Curve per assessment (aAUCpa) of QLQ H\&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, \& weight gain. The QLQ H\&N35 scoring algorithm was used for swallowing (questions 35-38) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient \& subscale, the subscale values at treatment-initiation \& assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive a placebo oral rinse and gargle or swish for 60 seconds and then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
- id
- OG000
- title
- Arm A (Placebo)
- description
- Patients receive acetylcysteine oral rinse and gargle or swish for 60 seconds then spit 5 times per day beginning within 3 days of the initiation of radiotherapy to 14 days following completion of radiotherapy.
- id
- OG001
- title
- Arm B (Rincinol)
- param Type
- MEAN
- population Description
- Patients who completed the QLQ H\&N Swallowing at all specified time points are included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 90 days after completion of radiation therapy
- title
- EORTC Quality of Life Questionnaire (QLQ) Swallowing
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice