Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT04162873
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
A Phase 2 study testing Celecoxib, Quality-of-Life Assessment and Questionnaire Administration in people with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Nasal Cavity and Paranasal Sinus Carcinoma
- What is being tested?
- Celecoxib, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2019to 26 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged ≥ 18 years.
- Advanced-stage (overall stage III and IV) head and neck cancers (sinonasal oral cavity, oropharynx, larynx, and hypopharynx) undergoing surgical resection and then adjuvant radiation. Primary and recurrence cases are acceptable
- Karnofsky performance status of >= 70
- Hemoglobin >= 10 g/dL
- Total bilirubin =< 2 mg/dL
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
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- Albumin > 3.5 g/dL
- Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 or creatinine clearance >= 30 mL/min by Cockcroft-Gault
- Serum potassium within normal limits
- Negative serum or urine pregnancy test at screening for women of childbearing potential
- Highly effective contraception for female subjects throughout the study and for at least 5 days after the last dose of study therapy if the risk of conception exists
- Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy
- Willing to maintain a diary of all opioids used during the trial for the treatment of pain
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
- Subject has verbally confirmed they are willing to complete adjuvant radiation therapy if recommended after surgery per protocol.
- Adjuvant radiation has been recommended by the institutional treatment planning conference with the best available data, but will be confirmed based on final surgical pathology.
Who cannot join
- 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:
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- Cerebrovascular accident (CVA), stroke, or cardiovascular thrombotic events (e.g. acute myocardial infarction).
- Chronic heart failure.
- Gastrointestinal bleeding, ulceration, peptic ulcer disease, or perforation of the stomach or intestines.
- Aspirin-sensitive asthma.
- Chronic kidney disease, stage 4 or 5
- 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.
- Note: Patients on effective anti-retroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial
- Known chronic hepatitis B virus (HBV) or hepatitis C virus infection with a detectable viral load.
- Note: Patients with an undetectable HBV viral load on appropriate suppressive therapy are eligible. Patients with an undetectable hepatitis C virus (HCV) viral load on appropriate treatment are eligible
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: RESILIENCE: Effect of Comprehensive Celecoxib Through Treatment for Advanced-Stage Head and Neck Cancer: A Randomized, Double-Blinded, Placebo-Controlled Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the number of days from surgery to initiation of radiation with the addition of celecoxib compared to placebo.
SECONDARY OBJECTIVES:
- To assess overall pain control and management for patients on celecoxib compared to placebo.
- Subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough.
- Patient satisfaction with pain control questionnaire.
- Narcotic consumption in daily total morphine equivalents averaged over a week. II. To assess functional outcomes 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.
- Conditions
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Nasal Cavity and Paranasal Sinus Carcinoma, Oral Cavity Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Being tested
- Celecoxib, Placebo, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Oropharyngeal Neoplasms, Paranasal Sinus Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177
Given PO or via feeding tube
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO or via feeding tube
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Celecoxib; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| 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. Receives: Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Secondary outcomes (9)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start27 Nov 2019
- Primary completion28 Feb 2023
- Study completion26 Apr 2023
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Cannon, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162873
- Sponsor's protocol ID
- HCI124211
- Other IDs
- NCI-2019-07104, HCI124211, P30CA042014
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2019
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESILIENCE: Effect of Comprehensive Celecoxib Through Treatment for Advanced-Stage Head and Neck Cancer: A Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04162873
- Acronym / sponsor ID
- HCI124211
- Conditions
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Nasal Cavity and Paranasal Sinus Carcinoma, Oral Cavity Carcinoma, Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To assess the number of days from surgery to initiation of radiation with the addition of celecoxib compared to placebo.
SECONDARY OBJECTIVES:
- To assess overall pain control and management for patients on celecoxib compared to placebo.
- Subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough.
- Patient satisfaction with pain control questionnaire.
- Narcotic consumption in daily total morphine equivalents averaged over a week. II. To assess functional outcomes 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib Arm | Experimental | Drug: Celecoxib, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
| Placebo Arm | Placebo comparator | Other: Placebo, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subject aged ≥ 18 years.
- Advanced-stage (overall stage III and IV) head and neck cancers (sinonasal oral cavity, oropharynx, larynx, and hypopharynx) undergoing surgical resection and then adjuvant radiation. Primary and recurrence cases are acceptable
- Karnofsky performance status of >= 70
- Hemoglobin >= 10 g/dL
- Total bilirubin =< 2 mg/dL
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177Given PO or via feeding tube | Drug | Celecoxib Arm |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO or via feeding tube | Other | Placebo Arm |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Celecoxib Arm, Placebo Arm |
| Questionnaire AdministrationAncillary studies | Other | Celecoxib Arm, Placebo Arm |
Primary outcome
The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy
Time frame: up to 3 months
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.
9 secondary outcomes
Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale.
Time frame: 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.
Time frame: 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.
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.
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
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)
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
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)
Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: up to 140 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cannon, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib, Quality-of-Life Assessment and Questionnaire Administration in people with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.