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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07104 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HCI124211 | Other Identifier | Huntsman Cancer Institute/University of Utah | |
| P30CA042014 | U.S. NIH Grant/Contract | View source |
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Insufficient funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.
PRIMARY OBJECTIVE:
I. To assess the number of days from surgery to initiation of radiation with the addition of celecoxib compared to placebo.
SECONDARY OBJECTIVES:
I. To assess overall pain control and management for patients on celecoxib compared to placebo.
III. To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
IV. To assess the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive celecoxib orally (PO) or via feeding tube twice daily (BID) starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO or via feeding tube BID starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib Arm | Experimental | Patients receive celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. |
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| Placebo Arm | Placebo Comparator | Patients receive placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Given PO or via feeding tube |
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| Measure | Description | Time Frame |
|---|---|---|
| The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy | 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. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Known distant metastatic disease or the tumor is deemed not surgically resectable
Established in a pain management clinic or has taken opioids regularly >= 6 months
Known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin)
Known hypersensitivity to celecoxib, aspirin, other non-steroidal anti-inflammatory drug (NSAID)s, or sulfonamides
Uncontrolled hypertension defined as blood pressure (BP) > 150 mmHg systolic or > 90 mmHg diastolic on three consecutive reads, taken in one sitting despite optimal antihypertensive treatment
Patients with a known history of the following:
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
The subject has uncontrolled, significant intercurrent or recent illness requiring systemic therapy, would preclude safe study participation, or is deemed clinically significant by the investigator
Known human immunodeficiency virus (HIV) infection with a detectable viral load within 6 months of the anticipated start of treatment.
Known chronic hepatitis B virus (HBV) or hepatitis C virus infection with a detectable viral load.
Subjects taking prohibited medications . A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment
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| Name | Affiliation | Role |
|---|---|---|
| Richard Cannon, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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13 participants were enrolled in the study. One participant withdrew from the study prior to receiving the first dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2023 |
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| Placebo | Other | Given PO or via feeding tube |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to 29 days from the start of study treatment |
| Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire. | 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 | post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery) |
| Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. | 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. | 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. |
| Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo | 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). | 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) |
| Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo | 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). | 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) |
| Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo | 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). | 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) |
| 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. | 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. | Up to 29 days after surgery (up to 32 days after initiation of study treatment) |
| To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. | 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. | Up to 29 days after surgery (up to 32 days after initiation of study treatment) |
| Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo. | 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. | up to 140 days |
| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Initial Histologic Grade | Staging systems are utilized in cancer care to standardize the extent of cancer. The TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. With this system, G describes the grade of the cancer. The grade score is based on Differentiation (1-Normal cells to 3-Very abnormal cells), Mitotic count (1 to 3; low score means fewer cells were dividing), and Tumor necrosis (0 to 2; lower score means less dying tissue). This has possible scores of GX (grade cannot be assessed due to incomplete information), G1 (score of 2-3), G2 (score of 4-5), and G3 (score of 6-8). | Count of Participants | Participants |
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| Prognostic Stage | Staging systems are utilized to standardize the extent of cancer, and the TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. The TNM status is tabulated to give a numerical status from Stage I (T1, N0, and M0) to Stage IVC (any T, any N, and M1). | Count of Participants | Participants |
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| Type of Head and Neck Cancer | Count of Participants | Participants |
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| Primary or Recurrent Tumor | Count of Participants | Participants |
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| Laterality | Count of Participants | Participants |
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| Primary Tumor pT | Staging systems are utilized in cancer care to standardize the extent of the cancer. The TNM (Tumor, Nodes, Metastasized) system is used for bladder cancer. With this system, T describes how far the primary tumor has grown and if it has grown into nearby tissue. This staging system ranges from T0 (No evidence of a primary tumor), T4a (tumor has grown beyond a certain point; moderately advanced), to T4b (tumor has grown further than T4a; very advanced). | Count of Participants | Participants |
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| Regional Lymph Nodes pN | Staging systems are utilized in cancer care to standardize the extent of the cancer. The TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. With this system, N describes if any cancer spread to lymph nodes. This staging system ranges from NX (cannot be assessed), N0 (no regional lymph node spread), N2a (cancer has spread to a single lymph node on the same side of the body as the primary tumor), N2b (cancer has spread to multiple lymph nodes on the same side of the body), to N3b (tumor extends to the supraclavicular fossa). | Count of Participants | Participants |
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| Distant Metastasis pM | Staging systems are utilized in cancer care to standardize the extent of the cancer. The TNM (Tumor, Nodes, Metastasized) system is used for squamous cell carcinomas. With this system, M describes if any cancer spread to other parts of the body. This staging system ranges from MX (Cancer spread cannot be assessed), M0 (cancer has not spread), to M1 (cancer has spread). | Count of Participants | Participants |
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| KPS Score | Assessment of current activity level was assessed utilizing Karnofsky Performance Status (KPS). 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. | Count of Participants | Participants |
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| Functional Oral Intake Scale | Assessment of current activity level was assessed utilizing Functional Oral Intake Scale (FOIS). FOIS is a standardized scale assessed by the treating investigator to determine 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). | Count of Participants | Participants |
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| Feeding Tube | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Pulse | Mean | Standard Deviation | bpm |
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| Blood Pressure | Mean | Standard Deviation | mmHg |
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| Respiratory Rate | Mean | Standard Deviation | Breaths per Minute |
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| Temperature | Mean | Standard Deviation | Fahrenheit |
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| Assessment of Overall Pain Control and Management for Patients | Patient satisfaction was assessed with a pain control questionnaire. The participants were asked how satisfied they were with their overall pain control over the last seven days. Satisfaction was measured from (0) Very Dissatisfied to (4) Very satisfied. | Count of Participants | Participants |
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| Visual Analog Scale | 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 No Pain (0), Mild Pain (0.5-4.4), Moderate Pain (4.5-7.4), and Severe Pain (7.5-10). | Count of Participants | Participants |
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| European Organization for Research &Treatment of Cancer Quality of Life Head & Neck (EORTC QLQ-HN43) | EORTC QLQ-HN43 is a 43-question survey of health-related quality of life of cancer patients assessing symptoms in the past week from "1 Not at All" to "4 Very Much". Scores are from 0-100; high scores represent a high response. A high functional scale score (FS; body image, social contact, &sexuality) represent a high level of function. A high symptom scale score (SS; anxiety, cough, pain, swallow, neurologic problems, senses, speech, social eating, weight loss, problems w/ skin, shoulder, wound healing, dry mouth, opening mouth, neck swelling, &teeth) represent a high level of symptoms | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy | 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. | 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. | Posted | Mean | Standard Deviation | days | up to 3 months |
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| Secondary | Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale. | 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. | One participant on the Celecoxib Arm withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint. | Posted | Mean | Standard Deviation | score on the pain intensity scale | Up to 29 days from the start of study treatment |
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| Secondary | Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire. | 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 | One participant on the Celcoxib Arm was not evaluable for this endpoint. | Posted | Mean | Standard Deviation | score on the pain control questionnaire | post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery) |
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| Secondary | Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo. | 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. | One participant on the Celecoxib Arm was not evaluable for this endpoint. | Posted | Mean | Standard Deviation | MME/day | 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. |
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| Secondary | Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo | 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). | One participant in the Celecoxib Arm was not evaluable for this outcome measure. | Posted | Count of Participants | Participants | 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) |
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| Secondary | Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo | 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). | One participant on the Celecoxib Arm was not evaluable for this outcome measure. | Posted | Count of Participants | Participants | 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) |
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| Secondary | Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo | 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). | One participant on the Celecoxib Arm was not evaluable for this outcome measure. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | 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. | One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Up to 29 days after surgery (up to 32 days after initiation of study treatment) |
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| Secondary | To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo. | 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. | One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint. | Posted | Mean | Standard Deviation | points | Up to 29 days after surgery (up to 32 days after initiation of study treatment) |
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| Secondary | Assessment of the Average Number of Treatment Days Missed During Adjuvant Radiation for Patients on Celecoxib Compared to Placebo. | 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. | One participant on the Celecoxib Arm was not evaluable for this outcome measure. | Posted | Count of Participants | Participants | up to 140 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 5 | 2 | 5 | 5 | 5 |
| EG001 | 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 | 0 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Allergic reaction | Immune system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphasia | Nervous system disorders | Systematic Assessment |
| ||
| Eye disorders - Other, specify | Eye disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Mucosal infection | Infections and infestations | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nervous system disorders - Other, specify | Nervous system disorders | Systematic Assessment |
| ||
| Oral hemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Postoperative hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment |
| ||
| Thrush | Infections and infestations | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Voice alteration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IIT Data Management Team | Research Compliance Office, Huntsman Cancer Institute | 801-213-6215 | IITDataManagement@hci.utah.edu |
| Oct 28, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D010255 | Paranasal Sinus Neoplasms |
| D009062 | Mouth Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009669 | Nose Neoplasms |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010254 | Paranasal Sinus Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D009059 | Mouth Diseases |
| D007818 | Laryngeal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| G1 |
|
| G2 |
|
| G3 |
|
| Stage IVA |
|
| Stage IVB |
|
| Stage IVC |
|
| Larynx |
|
| Oral Cavity |
|
| Oropharynx |
|
| Sinonasal |
|
| Recurrent |
|
| Left |
|
| Center/Both |
|
| pT3 |
|
| pT4a |
|
| rpT4a |
|
| mpT3 |
|
| pN2a |
|
| pN2b |
|
| pN3b |
|
| pNx |
|
| N2b |
|
| rpN0 |
|
| pMx |
|
| rpMx |
|
| Mx |
|
| Not Applicable |
|
| 90 - Able to carry on normal activity; minor signs or symptoms of disease |
|
| 80 - Normal activity with effort; some signs or symptoms of disease |
|
| 5 - Total Oral (multiple texture trials) - Mild Deficit |
|
| 6 - Total Oral (by mouth/restrictions) - Minimal Deficit |
|
| 7 - Regular Diet (by mouth/no restrictions) - Normal |
|
| No |
|
| Diastolic |
|
| 0) Very Dissatisfied |
|
| 1) Somewhat dissatisfied |
|
| 2) Neutral |
|
| 3) Somewhat satisfied |
|
| 4) Very satisfied |
|
| Mild Pain (0.5-4.4) |
|
| Moderate Pain (4.5-7.4) |
|
| Severe Pain (7.5-10) |
|
| With a Swallow |
|
| With a Cough |
|
| Body Image (FS) |
|
| Coughing (SS) |
|
| Dry mouth and sticky saliva (SS) |
|
| Neurological Problems (SS) |
|
| Opening mouth (SS) |
|
| Pain in the head and neck (SS) |
|
| Social Contact (FS) |
|
| Problems with senses (SS) |
|
| Skin Problems (SS) |
|
| Swelling in the neck (SS) |
|
| Social Eating (SS) |
|
| Speech Problems (SS) |
|
| Problems with Swallowing (SS) |
|
| Problems with Sexuality (FS) |
|
| Problems with teeth (SS) |
|
| Weight loss (SS) |
|
| Problems with Wound Healing (SS) |
|
| Shoulder Problems (SS) |
|
|
|
|
|
| OG001 |
| 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 |
|
|
|
|
| OG001 | 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 |
|
|
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
|
|
| OG001 | 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 |
|
|
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 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Unable to care for self; requires institutional or hospital care; disease may be progressing |
|
| Not Assessed |
|
| Unable to care for self; requires institutional or hospital care; disease may be progressing |
|
| Not Assessed |
|
| Total Oral |
|
| Regular Diet |
|
| Not Assessed |
|
| Total Oral |
|
| Regular Diet |
|
| Not Assessed |
|
| Not Assessed |
|
| Not Assessed |
|