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 swallowing capabilities was assessed by determining gastrostomy tube (G-tube) utilization at the following time points: pre-operation, day 14 of adjuvant therapy, and end of treatment (or last assessment). A G-tube is a tube inserted surgically through the abdomen and into the stomach to deliver liquids, medications, and nutrients directly into the stomach.
The responses in this outcome measure are Yes (G-tube is being utilized), No (G-tube is not being utilized), and Not Assessed (G-tube utilized was not assessed).
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
Yes
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 |
|---|
No
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 | 5 | 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
Yes
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 |
|---|
No
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 |
|---|
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)
Yes
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No
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 | 6 | 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
- 1
- group Id
- OG001
- value
- 2
- title
- Yes
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- No
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Not Assessed
- title
- Post-Operation
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Yes
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- No
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- Not Assessed
- title
- Mid-Radiation
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Yes
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- title
- No
- 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 swallowing capabilities was assessed by determining gastrostomy tube (G-tube) utilization at the following time points: pre-operation, day 14 of adjuvant therapy, and end of treatment (or last assessment). A G-tube is a tube inserted surgically through the abdomen and into the stomach to deliver liquids, medications, and nutrients directly into the stomach.
The responses in this outcome measure are Yes (G-tube is being utilized), No (G-tube is not being utilized), and Not Assessed (G-tube utilized was not assessed).
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
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Preserved source evidence · Not medical advice
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