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

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.

Time frame: 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.

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).

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)

Population: One participant on 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).

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)

Population: One participant in 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).

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)

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

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.

Time frame: 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.

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

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: up to 140 days

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

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.

Time frame: 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.

Time frame: 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.