NCT04162873 · OUTCOME
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer · Source last updated 2025-02-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Post-Operation (up to 29 days after surgery), Mid Radiation (up to 112 days after surgery), and End of Treatment (up to 146 days after surgery)
What was measured
Assessment of current activity level was assessed utilizing Functional Oral Intake Scale (FOIS) at the following time points: pre-operation, day 14 of adjuvant therapy, and end of treatment (or last assessment).
FOIS is a standardized scale assessed by the treating investigator to assess the functional level of oral intake in patients with dysphagia. The FOIS measures from 1 (Aspirates saliva, Nothing by mouth),2 (Tube dependent, Nothing by mouth/minimal trials), 3 (Tube dependent, Full trials by mouth), 4 (Total Oral Single, texture trials), 5 (Total Oral, Multiple texture trials), 6 (Total Oral, By mouth/ restrictions Minimal), and 7 (Regular diet, By mouth/ no restrictions). This assessment was measured for up to 5 months.
This assessment was measured at Post-Operation (up to 29 days after surgery), Mid Radiation (up to 112 days after surgery), and End of Treatment (up to 146 days after surgery).
Analysis population: One participant on the Celecoxib Arm was not evaluable for this outcome measure.
Groups in this outcome
Celecoxib Arm
Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Celecoxib: Given PO or via feeding tube
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Placebo Arm
Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Placebo: Given PO or via feeding tube
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Celecoxib Arm | 4 |
|---|
| Placebo Arm | 7 |
|---|
Reported measurements
Post-Operation
Aspirates Saliva
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Tube Dependent
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Total Oral
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Regular Diet
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Assessed
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Mid-Radiation
Aspirates Saliva
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Tube Dependent
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Total Oral
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Regular Diet
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Assessed
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
End of Treatment (or last assessment)
Aspirates Saliva
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Tube Dependent
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Total Oral
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Regular Diet
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Assessed
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Celecoxib Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo Arm | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Aspirates Saliva
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Tube Dependent
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- title
- Total Oral
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Regular Diet
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Not Assessed
- title
- Post-Operation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Aspirates Saliva
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Tube Dependent
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Total Oral
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Regular Diet
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Not Assessed
- title
- Mid-Radiation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Aspirates Saliva
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Tube Dependent
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Total Oral
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- title
- Regular Diet
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Not Assessed
- title
- End of Treatment (or last assessment)
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Assessment of current activity level was assessed utilizing Functional Oral Intake Scale (FOIS) at the following time points: pre-operation, day 14 of adjuvant therapy, and end of treatment (or last assessment).
FOIS is a standardized scale assessed by the treating investigator to assess the functional level of oral intake in patients with dysphagia. The FOIS measures from 1 (Aspirates saliva, Nothing by mouth),2 (Tube dependent, Nothing by mouth/minimal trials), 3 (Tube dependent, Full trials by mouth), 4 (Total Oral Single, texture trials), 5 (Total Oral, Multiple texture trials), 6 (Total Oral, By mouth/ restrictions Minimal), and 7 (Regular diet, By mouth/ no restrictions). This assessment was measured for up to 5 months.
This assessment was measured at Post-Operation (up to 29 days after surgery), Mid Radiation (up to 112 days after surgery), and End of Treatment (up to 146 days after surgery).
- groups
- description
- Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Celecoxib: Given PO or via feeding tube
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
- id
- OG000
- title
- Celecoxib Arm
- description
- Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
Placebo: Given PO or via feeding tube
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
- id
- OG001
- title
- Placebo Arm
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One participant on the Celecoxib Arm was not evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Post-Operation (up to 29 days after surgery), Mid Radiation (up to 112 days after surgery), and End of Treatment (up to 146 days after surgery)
- title
- Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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