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NCT04162873 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

→

secondary · POSTED

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.

→

secondary · POSTED

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.

→

secondary · POSTED

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.

→

secondary · POSTED

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.

→

secondary · POSTED

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · 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.

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
nct id
NCT04162873
qol key
qol-0007
source section id
NCT04162873-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
To Assess the Effect of Celecoxib Therapy on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) Compared to Placebo.
measure definition
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)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo.

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
nct id
NCT04162873
qol key
qol-0008
source section id
NCT04162873-om-0008
source outcome index
8
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo.
measure definition
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)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
nct id
NCT04162873
trial label
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0000
    source section id
    NCT04162873-om-0000
    source outcome index
    0
    endpoint
    The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy
    endpoint definition
    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 origin
    up to 3 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0001
    source section id
    NCT04162873-om-0001
    source outcome index
    1
    endpoint
    Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale.
    endpoint definition
    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 origin
    Up to 29 days from the start of study treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One participant on the Celecoxib Arm withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0002
    source section id
    NCT04162873-om-0002
    source outcome index
    2
    endpoint
    Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire.
    endpoint definition
    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 origin
    post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One participant on the Celcoxib Arm was not evaluable for this endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0003
    source section id
    NCT04162873-om-0003
    source outcome index
    3
    endpoint
    Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo.
    endpoint definition
    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 origin
    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.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One participant on the Celecoxib Arm was not evaluable for this endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0004
    source section id
    NCT04162873-om-0004
    source outcome index
    4
    endpoint
    Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
    endpoint definition
    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 origin
    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)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One participant in the Celecoxib Arm was not evaluable for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0005
    source section id
    NCT04162873-om-0005
    source outcome index
    5
    endpoint
    Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo
    endpoint definition
    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 origin
    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)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One participant on the Celecoxib Arm was not evaluable for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Celecoxib Arm
    regimen
    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
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    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
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Celecoxib Arm
    regimen
    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
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    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
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Celecoxib Arm
    regimen
    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
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    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
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Celecoxib Arm
    regimen
    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
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    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
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Celecoxib Arm
    regimen
    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
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    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
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Celecoxib Arm
    regimen
    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
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    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
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04162873-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    harm key
    EG000
    source section id
    NCT04162873-ae
    event group key
    EG000
    event group label
    Celecoxib Arm
    serious affected
    2
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    harm key
    EG001
    source section id
    NCT04162873-ae
    event group key
    EG001
    event group label
    Placebo Arm
    serious affected
    1
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    0
    collection period
    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.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    qol key
    qol-0007
    source section id
    NCT04162873-om-0007
    source outcome index
    7
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    To Assess the Effect of Celecoxib Therapy on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) Compared to Placebo.
    measure definition
    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)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-clinical-stage-iv-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajcc
    nct id
    NCT04162873
    qol key
    qol-0008
    source section id
    NCT04162873-om-0008
    source outcome index
    8
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo.
    measure definition
    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)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice