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NCT04162873 · OUTCOME

To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo.

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer · Source last updated 2025-02-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
points
Interval / dispersion
Standard Deviation
Time frame
Up to 29 days after surgery (up to 32 days after initiation of study treatment)

What was measured

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.

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

Groups in this outcome

Celecoxib Arm

Patients received celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Celecoxib: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Placebo Arm

Patients received placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continued until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. Placebo: Given PO or via feeding tube Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Celecoxib Arm4
Placebo Arm7

Reported measurements

General Symptom Factor
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm4.482.00Not reportedNot reportedNot reported
Placebo Arm3.062.12Not reportedNot reportedNot reported
Gastrointestinal Symptoms Factor
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm1.921.29Not reportedNot reportedNot reported
Placebo Arm1.762.45Not reportedNot reportedNot reported
HNC Symptoms
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm6.232.60Not reportedNot reportedNot reported
Placebo Arm3.392.62Not reportedNot reportedNot reported
HNC Treatment-Related Symptoms
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm3.551.81Not reportedNot reportedNot reported
Placebo Arm1.602.05Not reportedNot reportedNot reported
General Cancer Related Symptoms
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm3.881.70Not reportedNot reportedNot reported
Placebo Arm2.752.12Not reportedNot reportedNot reported
Head and Neck Cancer Related Symptoms
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm4.581.92Not reportedNot reportedNot reported
Placebo Arm2.371.84Not reportedNot reportedNot reported
Symptoms Interference with Daily Activities
Values in points · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Celecoxib Arm6.422.18Not reportedNot reportedNot reported
Placebo Arm4.452.66Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.00
        value
        4.48
      2. group Id
        OG001
        spread
        2.12
        value
        3.06
    title
    General Symptom Factor
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.29
        value
        1.92
      2. group Id
        OG001
        spread
        2.45
        value
        1.76
    title
    Gastrointestinal Symptoms Factor
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.60
        value
        6.23
      2. group Id
        OG001
        spread
        2.62
        value
        3.39
    title
    HNC Symptoms
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.81
        value
        3.55
      2. group Id
        OG001
        spread
        2.05
        value
        1.60
    title
    HNC Treatment-Related Symptoms
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.70
        value
        3.88
      2. group Id
        OG001
        spread
        2.12
        value
        2.75
    title
    General Cancer Related Symptoms
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.92
        value
        4.58
      2. group Id
        OG001
        spread
        1.84
        value
        2.37
    title
    Head and Neck Cancer Related Symptoms
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.18
        value
        6.42
      2. group Id
        OG001
        spread
        2.66
        value
        4.45
    title
    Symptoms Interference with Daily Activities
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      7
    units
    Participants
description
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.
dispersion Type
Standard Deviation
groups
  1. description
    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
    id
    OG000
    title
    Celecoxib Arm
  2. description
    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
    id
    OG001
    title
    Placebo Arm
param Type
MEAN
population Description
One participant on Arm 1 withdrew consent from the study treatment before the Post-Operation visit and was not evaluable for this endpoint.
reporting Status
POSTED
time Frame
Up to 29 days after surgery (up to 32 days after initiation of study treatment)
title
To Assess the Effect of Celecoxib Therapy on the MDASI-HN Questionnaire Compared to Placebo.
type
SECONDARY
unit Of Measure
points

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Preserved source evidence · Not medical advice