Trial Outcomes & Findings for Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer (NCT NCT04162873)

Last Updated: 2025-02-12

Results Overview

The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. This outcome measure will report the mean number of days from surgery to the initiation of radiation and adjuvant therapy for the Celecoxib and Placebo Arms.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

up to 3 months

Results posted on

2025-02-12

Participant Flow

13 participants were enrolled in the study. One participant withdrew from the study prior to receiving the first dose of study drug.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	5	7
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib Arm n=5 Participants 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 n=7 Participants 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	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	60.40 years STANDARD_DEVIATION 7.02 • n=5 Participants	65.14 years STANDARD_DEVIATION 20.24 • n=7 Participants	63.17 years STANDARD_DEVIATION 15.72 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants
Initial Histologic Grade Gx	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Initial Histologic Grade G1	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Initial Histologic Grade G2	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Initial Histologic Grade G3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prognostic Stage Stage III	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Prognostic Stage Stage IVA	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Prognostic Stage Stage IVB	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prognostic Stage Stage IVC	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Type of Head and Neck Cancer Hypopharynx	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Type of Head and Neck Cancer Larynx	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Type of Head and Neck Cancer Oral Cavity	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Type of Head and Neck Cancer Oropharynx	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Type of Head and Neck Cancer Sinonasal	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Primary or Recurrent Tumor Primary	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Primary or Recurrent Tumor Recurrent	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Laterality Right	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Laterality Left	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Laterality Center/Both	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Primary Tumor pT pT1	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Primary Tumor pT pT3	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Primary Tumor pT pT4a	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Primary Tumor pT rpT4a	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Primary Tumor pT mpT3	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Regional Lymph Nodes pN pN0	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Regional Lymph Nodes pN pN2a	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Regional Lymph Nodes pN pN2b	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Regional Lymph Nodes pN pN3b	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Regional Lymph Nodes pN pNx	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Regional Lymph Nodes pN N2b	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Regional Lymph Nodes pN rpN0	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Distant Metastasis pM pM0	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Distant Metastasis pM pMx	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Distant Metastasis pM rpMx	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Distant Metastasis pM Mx	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Distant Metastasis pM Not Applicable	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
KPS Score 100 - Normal; no complaints; no evidence of disease	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
KPS Score 90 - Able to carry on normal activity; minor signs or symptoms of disease	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
KPS Score 80 - Normal activity with effort; some signs or symptoms of disease	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Functional Oral Intake Scale 3 - Tube Dependent (full trials by mouth) - Severe Deficit	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Functional Oral Intake Scale 5 - Total Oral (multiple texture trials) - Mild Deficit	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Functional Oral Intake Scale 6 - Total Oral (by mouth/restrictions) - Minimal Deficit	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Functional Oral Intake Scale 7 - Regular Diet (by mouth/no restrictions) - Normal	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Feeding Tube Yes	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Feeding Tube No	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Height	170.68 cm STANDARD_DEVIATION 8.55 • n=5 Participants	177.66 cm STANDARD_DEVIATION 11.34 • n=7 Participants	174.75 cm STANDARD_DEVIATION 10.47 • n=5 Participants
Weight	83.12 kg STANDARD_DEVIATION 20.44 • n=5 Participants	85.63 kg STANDARD_DEVIATION 21.10 • n=7 Participants	84.58 kg STANDARD_DEVIATION 19.91 • n=5 Participants
BMI	28.20 kg/m^2 STANDARD_DEVIATION 4.95 • n=5 Participants	26.95 kg/m^2 STANDARD_DEVIATION 4.83 • n=7 Participants	27.47 kg/m^2 STANDARD_DEVIATION 4.69 • n=5 Participants
Pulse	76.40 bpm STANDARD_DEVIATION 7.70 • n=5 Participants	84.14 bpm STANDARD_DEVIATION 21.43 • n=7 Participants	80.92 bpm STANDARD_DEVIATION 16.97 • n=5 Participants
Blood Pressure Systolic	118.20 mmHg STANDARD_DEVIATION 11.92 • n=5 Participants	135.71 mmHg STANDARD_DEVIATION 12.39 • n=7 Participants	128.42 mmHg STANDARD_DEVIATION 14.72 • n=5 Participants
Blood Pressure Diastolic	77.20 mmHg STANDARD_DEVIATION 6.72 • n=5 Participants	77.71 mmHg STANDARD_DEVIATION 7.63 • n=7 Participants	77.50 mmHg STANDARD_DEVIATION 6.95 • n=5 Participants
Respiratory Rate	18 Breaths per Minute STANDARD_DEVIATION 1.41 • n=5 Participants	16 Breaths per Minute STANDARD_DEVIATION 1.15 • n=7 Participants	16.83 Breaths per Minute STANDARD_DEVIATION 1.59 • n=5 Participants
Temperature	97.98 Fahrenheit STANDARD_DEVIATION 0.51 • n=5 Participants	97.98 Fahrenheit STANDARD_DEVIATION 0.52 • n=7 Participants	97.98 Fahrenheit STANDARD_DEVIATION 0.49 • n=5 Participants
Assessment of Overall Pain Control and Management for Patients Not Assessed	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Assessment of Overall Pain Control and Management for Patients 0) Very Dissatisfied	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Assessment of Overall Pain Control and Management for Patients 1) Somewhat dissatisfied	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Assessment of Overall Pain Control and Management for Patients 2) Neutral	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Assessment of Overall Pain Control and Management for Patients 3) Somewhat satisfied	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Assessment of Overall Pain Control and Management for Patients 4) Very satisfied	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Visual Analog Scale While at Rest · No Pain (0-0.5)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Visual Analog Scale While at Rest · Mild Pain (0.5-4.4)	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Visual Analog Scale While at Rest · Moderate Pain (4.5-7.4)	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Visual Analog Scale While at Rest · Severe Pain (7.5-10)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Visual Analog Scale With a Swallow · No Pain (0-0.5)	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Visual Analog Scale With a Swallow · Mild Pain (0.5-4.4)	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Visual Analog Scale With a Swallow · Moderate Pain (4.5-7.4)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Visual Analog Scale With a Swallow · Severe Pain (7.5-10)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Visual Analog Scale With a Cough · No Pain (0-0.5)	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Visual Analog Scale With a Cough · Mild Pain (0.5-4.4)	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Visual Analog Scale With a Cough · Moderate Pain (4.5-7.4)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Visual Analog Scale With a Cough · Severe Pain (7.5-10)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Anxiety (SS)	70.0 units on a scale STANDARD_DEVIATION 24.72 • n=5 Participants	59.52 units on a scale STANDARD_DEVIATION 33.13 • n=7 Participants	63.89 units on a scale STANDARD_DEVIATION 29.16 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Body Image (FS)	46.67 units on a scale STANDARD_DEVIATION 36.35 • n=5 Participants	92.06 units on a scale STANDARD_DEVIATION 8.40 • n=7 Participants	73.15 units on a scale STANDARD_DEVIATION 32.64 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Coughing (SS)	26.67 units on a scale STANDARD_DEVIATION 27.89 • n=5 Participants	4.76 units on a scale STANDARD_DEVIATION 12.60 • n=7 Participants	13.89 units on a scale STANDARD_DEVIATION 22.29 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Dry mouth and sticky saliva (SS)	36.67 units on a scale STANDARD_DEVIATION 27.39 • n=5 Participants	21.43 units on a scale STANDARD_DEVIATION 15.85 • n=7 Participants	27.78 units on a scale STANDARD_DEVIATION 21.71 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Neurological Problems (SS)	13.33 units on a scale STANDARD_DEVIATION 29.81 • n=5 Participants	4.76 units on a scale STANDARD_DEVIATION 12.60 • n=7 Participants	8.33 units on a scale STANDARD_DEVIATION 20.72 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Opening mouth (SS)	66.67 units on a scale STANDARD_DEVIATION 33.33 • n=5 Participants	28.57 units on a scale STANDARD_DEVIATION 29.99 • n=7 Participants	44.44 units on a scale STANDARD_DEVIATION 35.77 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Pain in the head and neck (SS)	66.67 units on a scale STANDARD_DEVIATION 27.64 • n=5 Participants	38.10 units on a scale STANDARD_DEVIATION 26.29 • n=7 Participants	50.00 units on a scale STANDARD_DEVIATION 29.52 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Social Contact (FS)	46.67 units on a scale STANDARD_DEVIATION 44.72 • n=5 Participants	95.24 units on a scale STANDARD_DEVIATION 12.60 • n=7 Participants	75.00 units on a scale STANDARD_DEVIATION 37.94 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Problems with senses (SS)	20 units on a scale STANDARD_DEVIATION 27.39 • n=5 Participants	4.76 units on a scale STANDARD_DEVIATION 8.13 • n=7 Participants	11.11 units on a scale STANDARD_DEVIATION 19.25 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Skin Problems (SS)	15.56 units on a scale STANDARD_DEVIATION 21.66 • n=5 Participants	3.17 units on a scale STANDARD_DEVIATION 8.40 • n=7 Participants	8.33 units on a scale STANDARD_DEVIATION 15.80 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Swelling in the neck (SS)	53.33 units on a scale STANDARD_DEVIATION 38.01 • n=5 Participants	19.05 units on a scale STANDARD_DEVIATION 26.23 • n=7 Participants	33.33 units on a scale STANDARD_DEVIATION 34.82 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Social Eating (SS)	63.33 units on a scale STANDARD_DEVIATION 27.39 • n=5 Participants	22.62 units on a scale STANDARD_DEVIATION 20.25 • n=7 Participants	39.58 units on a scale STANDARD_DEVIATION 30.59 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Speech Problems (SS)	62.67 units on a scale STANDARD_DEVIATION 36.70 • n=5 Participants	24.76 units on a scale STANDARD_DEVIATION 35.43 • n=7 Participants	40.56 units on a scale STANDARD_DEVIATION 39.44 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Problems with Swallowing (SS)	48.33 units on a scale STANDARD_DEVIATION 35.06 • n=5 Participants	15.48 units on a scale STANDARD_DEVIATION 18.90 • n=7 Participants	29.17 units on a scale STANDARD_DEVIATION 30.46 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Problems with Sexuality (FS)	50.00 units on a scale STANDARD_DEVIATION 47.14 • n=5 Participants	66.67 units on a scale STANDARD_DEVIATION 42.16 • n=7 Participants	59.09 units on a scale STANDARD_DEVIATION 43.05 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Problems with teeth (SS)	51.11 units on a scale STANDARD_DEVIATION 30.02 • n=5 Participants	22.22 units on a scale STANDARD_DEVIATION 19.25 • n=7 Participants	34.26 units on a scale STANDARD_DEVIATION 27.40 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Weight loss (SS)	26.67 units on a scale STANDARD_DEVIATION 43.46 • n=5 Participants	23.81 units on a scale STANDARD_DEVIATION 31.71 • n=7 Participants	25 units on a scale STANDARD_DEVIATION 35.18 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Problems with Wound Healing (SS)	20 units on a scale STANDARD_DEVIATION 29.81 • n=5 Participants	28.57 units on a scale STANDARD_DEVIATION 40.50 • n=7 Participants	25.00 units on a scale STANDARD_DEVIATION 35.18 • n=5 Participants
European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) Shoulder Problems (SS)	13.33 units on a scale STANDARD_DEVIATION 29.81 • n=5 Participants	0 units on a scale STANDARD_DEVIATION 0 • n=7 Participants	5.56 units on a scale STANDARD_DEVIATION 19.25 • n=5 Participants

PRIMARY outcome

Timeframe: up to 3 months

Population: Two participants in the Celecoxib Arm did not receive adjuvant radiation therapy and were not evaluable for this endpoint. One other participant from the Celecoxib Arm only received two doses of study treatment and was not evaluable for this endpoint. One participant in the Placebo Arm did not receive adjuvant radiation therapy and was not evaluable for this endpoint.

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=2 Participants 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 n=6 Participants 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
The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy	53.5 days Standard Deviation 9.19	60.17 days Standard Deviation 20.04

SECONDARY outcome

Timeframe: Up to 29 days from the start of study treatment

Population: One participant on the Celecoxib Arm withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.

Assessment of subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. The subjects rated their pain from 0-10 on the pain intensity scale. Scores are reported as means of the pain score with standard deviation. This outcome is reported scores collected at the post-surgery visit; 9 to 29 days after the start of study treatment.

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale. With a Cough	4.25 score on the pain intensity scale Standard Deviation 1.44	1.79 score on the pain intensity scale Standard Deviation 2.80
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale. While at Rest	4.63 score on the pain intensity scale Standard Deviation 2.29	1.21 score on the pain intensity scale Standard Deviation 1.22
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale. With a Swallow	5.00 score on the pain intensity scale Standard Deviation 2.80	1.64 score on the pain intensity scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery)

Population: One participant on the Celcoxib Arm was not evaluable for this endpoint.

Patient satisfaction was assessed with a pain control questionnaire. The participants were asked questions about their pain satisfaction over the last seven days. The pain control questionnaire was scored from 0-100, with smaller values indicating poor pain control satisfaction and larger values indicating excellent pain control satisfaction. This outcome was assessed at post-surgery and end of treatment for up to 5 months

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire. Post-Operation	79.86 score on the pain control questionnaire Standard Deviation 17.77	96.82 score on the pain control questionnaire Standard Deviation 5.42
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire. End of Treatment	80.55 score on the pain control questionnaire Standard Deviation 21.52	88.89 score on the pain control questionnaire Standard Deviation 13.61

SECONDARY outcome

Timeframe: Post-Surgery (1-7 days) up to 7 days, Post-Surgery (1-14 days) up to 14 days, Post-Surgery (1-26 days) up to 26 days, Post-Surgery (1-35 days) up to 35 days, and End of Treatment up to 146 days.

Population: One participant on the Celecoxib Arm was not evaluable for this endpoint.

Narcotic consumption was assessed in daily total morphine equivalents averaged over a week. This outcome was assessed at 7 days after surgery and 35 days after surgery. Morphine equivalent dose (MED) is the amount of opioid prescription drugs a patient is taking per day. MED is the sum of the total morphine milligram equivalents (MMEs), a common unit for assessing milligrams of morphine, dose per day. The Post-Surgery (1-7 days) time point is MED from 1 to 7 days after surgery. The Post-Surgery (1-14 days) time point is MED from 1 to 14 days after surgery. The Post-Surgery (1-26 days) time point is MED from 1 to 26 days after surgery. The Post-Surgery (1-35 days) time point is MED from 1 to 35 days after surgery. The End of Treatment time point is MED from 1 to 146 days after surgery.

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. Post-Surgery (1-26 days)	9.88 MME/day Standard Deviation 15.67	13.46 MME/day Standard Deviation 22.54
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. Post-Surgery (1-7 days)	22.19 MME/day Standard Deviation 22.20	28.73 MME/day Standard Deviation 34.51
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. Post-Surgery (1-14 days)	14.24 MME/day Standard Deviation 18.74	20.18 MME/day Standard Deviation 28.78
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. Post-Surgery (1-21 days)	12.82 MME/day Standard Deviation 17.21	15.85 MME/day Standard Deviation 25.01
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. Post-Surgery (1-35 days)	8.76 MME/day Standard Deviation 14.32	12.14 MME/day Standard Deviation 20.91
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. End of Treatment	6.64 MME/day Standard Deviation 7.32	11.02 MME/day Standard Deviation 16.96

SECONDARY outcome

Timeframe: 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)

Population: One participant in the Celecoxib Arm was not evaluable for this outcome measure.

Assessment of current activity level was assessed utilizing Karnofsky Performance Status (KPS) at the following time points: pre-operation, day 14 of adjuvant therapy, and end of treatment (or last assessment). The KPS is a scale used to measure a subject's ability to perform daily tasks from 100 Normal no complaints no evidence of disease, 50 Requires considerable assistance and frequent medical care, and 0 Dead. 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).

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post- Operation · Unable to care for self; requires institutional or hospital care; disease may be progressing	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid Radiation · Able to carry on normal activity and to work; no special care needed.	2 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment · Not Assessed	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post- Operation · Able to carry on normal activity and to work; no special care needed.	2 Participants	5 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post- Operation · Unable to work; able to live at home & care for personal needs; varying amount of assistance needed.	2 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post- Operation · Not Assessed	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid Radiation · Unable to work; able to live at home & care for personal needs; varying amount of assistance needed.	0 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid Radiation · Unable to care for self; requires institutional or hospital care; disease may be progressing	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid Radiation · Not Assessed	2 Participants	3 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment · Able to carry on normal activity and to work; no special care needed.	2 Participants	6 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment · Unable to work; able to live at home & care for personal needs; varying amount of assistance needed.	2 Participants	1 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment · Unable to care for self; requires institutional or hospital care; disease may be progressing	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Population: One participant on the Celecoxib Arm was not evaluable for this outcome measure.

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).

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Tube Dependent	1 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Not Assessed	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Not Assessed	2 Participants	3 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or last assessment) · Total Oral	3 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or last assessment) · Regular Diet	0 Participants	4 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Aspirates Saliva	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Total Oral	3 Participants	4 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Regular Diet	0 Participants	1 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Aspirates Saliva	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Tube Dependent	1 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Total Oral	1 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Regular Diet	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or last assessment) · Aspirates Saliva	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or last assessment) · Tube Dependent	1 Participants	1 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or last assessment) · Not Assessed	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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)

Population: One participant on the Celecoxib Arm was not evaluable for this outcome measure.

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).

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Yes	1 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · No	3 Participants	5 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Post-Operation · Not Assessed	0 Participants	0 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Yes	1 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · No	1 Participants	2 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo Mid-Radiation · Not Assessed	2 Participants	3 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or Last Assessment) · Yes	2 Participants	1 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or Last Assessment) · No	2 Participants	6 Participants
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo End of Treatment (or Last Assessment) · Not Assessed	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 29 days after surgery (up to 32 days after initiation of study treatment)

Population: One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.

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.

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
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. Opening mouth (SS)	66.67 units on a scale Standard Deviation 47.14	42.86 units on a scale Standard Deviation 25.20
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. Pain in the head and neck (SS)	41.67 units on a scale Standard Deviation 20.41	27.38 units on a scale Standard Deviation 28.35
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. Social contact (FS)	50 units on a scale Standard Deviation 19.25	61.90 units on a scale Standard Deviation 35.63
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. Problems with senses (SS)	25 units on a scale Standard Deviation 21.52	28.57 units on a scale Standard Deviation 35.63
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. Shoulder problems (SS)	45.83 units on a scale Standard Deviation 45.90	9.52 units on a scale Standard Deviation 13.11
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. Skin problems (SS)	25 units on a scale Standard Deviation 13.98	20.63 units on a scale Standard Deviation 31.71
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. Swelling in the neck (SS)	66.67 units on a scale Standard Deviation 47.14	57.14 units on a scale Standard Deviation 46
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. Social eating (SS)	50 units on a scale Standard Deviation 43.3	26.19 units on a scale Standard Deviation 29.83
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. Problems with Swallowing (SS)	45.83 units on a scale Standard Deviation 29.46	29.76 units on a scale Standard Deviation 33.97
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. Problems with Sexuality (FS)	33.33 units on a scale Standard Deviation 33.33	80.95 units on a scale Standard Deviation 26.23
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. Problems with teeth (SS)	22.22 units on a scale Standard Deviation 27.22	22.22 units on a scale Standard Deviation 24.84
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. Weight loss (SS)	25 units on a scale Standard Deviation 16.67	14.29 units on a scale Standard Deviation 26.23
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. Problems with wound healing (SS)	33.33 units on a scale Standard Deviation 47.14	28.57 units on a scale Standard Deviation 23
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. Anxiety (SS)	50 units on a scale Standard Deviation 36	50 units on a scale Standard Deviation 34.69
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. Body Image (FS)	36.11 units on a scale Standard Deviation 31.91	60.32 units on a scale Standard Deviation 34.46
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. Coughing (SS)	16.67 units on a scale Standard Deviation 19.25	9.52 units on a scale Standard Deviation 16.27
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. Dry mouth and sticky saliva (SS)	54.17 units on a scale Standard Deviation 31.55	42.86 units on a scale Standard Deviation 33.13
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. Neurological problems (SS)	44.44 units on a scale Standard Deviation 50.92	9.52 units on a scale Standard Deviation 16.27
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. Speech problems (SS)	55.24 units on a scale Standard Deviation 26.15	48.10 units on a scale Standard Deviation 34.53

SECONDARY outcome

Timeframe: Up to 29 days after surgery (up to 32 days after initiation of study treatment)

Population: One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.

This outcome will report the quality of life questionnaire, the M. D. Anderson symptom inventory head neck (MDASI-HN) at the Post-Operation Visit. This was assessed up to 29 days after surgery (up to 32 days after initiation of study treatment). MDASI-HN is a 28-question, 2-part questionnaire for patients with head and neck cancer that assesses the severity of symptoms and impact on daily life. In Part I, subjects indicated how severe their symptoms were from "0 Not present" to "10 As Bad as You can Imagine". In Part II, subjects indicated how symptoms have interfered with their live from "0 Did not Interfere" to "10 Interfered Completely". This assessment was scored according to the The M. D. Anderson Symptom Inventory User Guide.

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. General Symptom Factor	4.48 points Standard Deviation 2.00	3.06 points Standard Deviation 2.12
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. Gastrointestinal Symptoms Factor	1.92 points Standard Deviation 1.29	1.76 points Standard Deviation 2.45
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. HNC Symptoms	6.23 points Standard Deviation 2.60	3.39 points Standard Deviation 2.62
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. HNC Treatment-Related Symptoms	3.55 points Standard Deviation 1.81	1.60 points Standard Deviation 2.05
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. General Cancer Related Symptoms	3.88 points Standard Deviation 1.70	2.75 points Standard Deviation 2.12
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. Head and Neck Cancer Related Symptoms	4.58 points Standard Deviation 1.92	2.37 points Standard Deviation 1.84
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. Symptoms Interference with Daily Activities	6.42 points Standard Deviation 2.18	4.45 points Standard Deviation 2.66

SECONDARY outcome

Timeframe: up to 140 days

Population: One participant on the Celecoxib Arm was not evaluable for this outcome measure.

This outcome will report the number of participants who missed treatment days during adjuvant radiation, who did not miss any treatment days during adjuvant radiation, and the number of participants who did not start adjuvant radiation therapy.

Outcome measures

Outcome measures
Measure	Celecoxib Arm n=4 Participants 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 n=7 Participants 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
Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo. No Adjuvant Radiation Therapy	2 Participants	1 Participants
Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo. No days of missed adjuvant radiation therapy	2 Participants	5 Participants
Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo. More than 0 days of adjuvant radiation therapy	0 Participants	1 Participants

Adverse Events

Celecoxib Arm

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Celecoxib Arm n=5 participants at risk 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 n=7 participants at risk 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
Vascular disorders Hypotension	20.0% 1/5 • Number of events 1 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.	0.00% 0/7 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/5 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.	0.00% 0/7 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/5 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.	14.3% 1/7 • Number of events 1 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.
Nervous system disorders Syncope	20.0% 1/5 • Number of events 1 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.	0.00% 0/7 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.
Vascular disorders Thromboembolic event	20.0% 1/5 • Number of events 1 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.	0.00% 0/7 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.
Injury, poisoning and procedural complications Wound dehiscence	20.0% 1/5 • Number of events 1 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.	0.00% 0/7 • Collection of adverse events began on the first dose of study medication until the end of treatment visit (or until a new cancer treatment is initiated). Adverse events were collected for up to 5 months.

Other adverse events

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place