To Assess the Effect of Celecoxib Therapy on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) 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
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Up to 29 days after surgery (up to 32 days after initiation of study treatment)
What was measured
The EORTC QLQ-HN43 is a 43-question assessment for determining the health-related quality of life of head and neck cancer patients participating in clinical trials. Patients indicate which symptoms/problems they have experienced during the past week, from "1 Not at All" to "4 Very Much".
The assessment was scored according to the "EORTC QLQ-C30 Scoring Manual", reporting data as 19 subscales with scores from 0-100. A high scale score represents a higher response level.
A high functional scale score (FS) represent a high/healthy level of function and includes body image, social contact, \& sexuality A high symptom scale score (SS) represent a high level of symptomatology/problems and includes anxiety, cough, head and neck pain, swallowing, neurologic problems, senses, speech, social eating, weight loss, problems w/ skin, shoulder, wound healing, dry mouth, opening mouth, neck swelling, \& teeth.
This outcome will report the mean score of each subscale.
Analysis population: One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
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
Anxiety (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
50
36
Not reported
Not reported
Not reported
Placebo Arm
50
34.69
Not reported
Not reported
Not reported
Body Image (FS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
36.11
31.91
Not reported
Not reported
Not reported
Placebo Arm
60.32
34.46
Not reported
Not reported
Not reported
Coughing (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
16.67
19.25
Not reported
Not reported
Not reported
Placebo Arm
9.52
16.27
Not reported
Not reported
Not reported
Dry mouth and sticky saliva (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
54.17
31.55
Not reported
Not reported
Not reported
Placebo Arm
42.86
33.13
Not reported
Not reported
Not reported
Neurological problems (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
44.44
50.92
Not reported
Not reported
Not reported
Placebo Arm
9.52
16.27
Not reported
Not reported
Not reported
Opening mouth (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
66.67
47.14
Not reported
Not reported
Not reported
Placebo Arm
42.86
25.20
Not reported
Not reported
Not reported
Pain in the head and neck (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
41.67
20.41
Not reported
Not reported
Not reported
Placebo Arm
27.38
28.35
Not reported
Not reported
Not reported
Social contact (FS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
50
19.25
Not reported
Not reported
Not reported
Placebo Arm
61.90
35.63
Not reported
Not reported
Not reported
Problems with senses (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
25
21.52
Not reported
Not reported
Not reported
Placebo Arm
28.57
35.63
Not reported
Not reported
Not reported
Shoulder problems (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
45.83
45.90
Not reported
Not reported
Not reported
Placebo Arm
9.52
13.11
Not reported
Not reported
Not reported
Skin problems (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
25
13.98
Not reported
Not reported
Not reported
Placebo Arm
20.63
31.71
Not reported
Not reported
Not reported
Swelling in the neck (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
66.67
47.14
Not reported
Not reported
Not reported
Placebo Arm
57.14
46
Not reported
Not reported
Not reported
Social eating (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
50
43.3
Not reported
Not reported
Not reported
Placebo Arm
26.19
29.83
Not reported
Not reported
Not reported
Speech problems (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
55.24
26.15
Not reported
Not reported
Not reported
Placebo Arm
48.10
34.53
Not reported
Not reported
Not reported
Problems with Swallowing (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
45.83
29.46
Not reported
Not reported
Not reported
Placebo Arm
29.76
33.97
Not reported
Not reported
Not reported
Problems with Sexuality (FS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
33.33
33.33
Not reported
Not reported
Not reported
Placebo Arm
80.95
26.23
Not reported
Not reported
Not reported
Problems with teeth (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
22.22
27.22
Not reported
Not reported
Not reported
Placebo Arm
22.22
24.84
Not reported
Not reported
Not reported
Weight loss (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
25
16.67
Not reported
Not reported
Not reported
Placebo Arm
14.29
26.23
Not reported
Not reported
Not reported
Problems with wound healing (SS)
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Celecoxib Arm
33.33
47.14
Not reported
Not reported
Not reported
Placebo Arm
28.57
23
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
36
value
50
group Id
OG001
spread
34.69
value
50
title
Anxiety (SS)
categories
measurements
group Id
OG000
spread
31.91
value
36.11
group Id
OG001
spread
34.46
value
60.32
title
Body Image (FS)
categories
measurements
group Id
OG000
spread
19.25
value
16.67
group Id
OG001
spread
16.27
value
9.52
title
Coughing (SS)
categories
measurements
group Id
OG000
spread
31.55
value
54.17
group Id
OG001
spread
33.13
value
42.86
title
Dry mouth and sticky saliva (SS)
categories
measurements
group Id
OG000
spread
50.92
value
44.44
group Id
OG001
spread
16.27
value
9.52
title
Neurological problems (SS)
categories
measurements
group Id
OG000
spread
47.14
value
66.67
group Id
OG001
spread
25.20
value
42.86
title
Opening mouth (SS)
categories
measurements
group Id
OG000
spread
20.41
value
41.67
group Id
OG001
spread
28.35
value
27.38
title
Pain in the head and neck (SS)
categories
measurements
group Id
OG000
spread
19.25
value
50
group Id
OG001
spread
35.63
value
61.90
title
Social contact (FS)
categories
measurements
group Id
OG000
spread
21.52
value
25
group Id
OG001
spread
35.63
value
28.57
title
Problems with senses (SS)
categories
measurements
group Id
OG000
spread
45.90
value
45.83
group Id
OG001
spread
13.11
value
9.52
title
Shoulder problems (SS)
categories
measurements
group Id
OG000
spread
13.98
value
25
group Id
OG001
spread
31.71
value
20.63
title
Skin problems (SS)
categories
measurements
group Id
OG000
spread
47.14
value
66.67
group Id
OG001
spread
46
value
57.14
title
Swelling in the neck (SS)
denoms
counts
group Id
OG000
value
4
group Id
OG001
value
7
units
Participants
description
The EORTC QLQ-HN43 is a 43-question assessment for determining the health-related quality of life of head and neck cancer patients participating in clinical trials. Patients indicate which symptoms/problems they have experienced during the past week, from "1 Not at All" to "4 Very Much".
The assessment was scored according to the "EORTC QLQ-C30 Scoring Manual", reporting data as 19 subscales with scores from 0-100. A high scale score represents a higher response level.
A high functional scale score (FS) represent a high/healthy level of function and includes body image, social contact, \& sexuality A high symptom scale score (SS) represent a high level of symptomatology/problems and includes anxiety, cough, head and neck pain, swallowing, neurologic problems, senses, speech, social eating, weight loss, problems w/ skin, shoulder, wound healing, dry mouth, opening mouth, neck swelling, \& teeth.
This outcome will report the mean score of each subscale.
dispersion Type
Standard Deviation
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
MEAN
population Description
One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
reporting Status
POSTED
time Frame
Up to 29 days after surgery (up to 32 days after initiation of study treatment)
title
To Assess the Effect of Celecoxib Therapy on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) Compared to Placebo.
Triangle