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NCT00293462 · OUTCOME

Comparison of Combined Mean Score on the Pain Questionnaire by Group

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2021-07-30

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Up to 3 months

What was measured

Severity and quality of pain was measured using a pain questionnaire developed for this study with total scores ranging from 0 (no pain) to 10 (most intense pain) with higher scores indicating a greater level of pain. The questionnaire was administered at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were combined to compute one mean to determine overall pain intensity score during the course of the study

Analysis population: Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.

Groups in this outcome

Arm I: GM-CSF Group (GG)

Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

Arm II: Salt & Soda Group (SS)

Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.

Arm III: Salt & Soda Switched to GM-CSF (SG)

Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.

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

Analysis denominator · Participants

GroupSource count
Arm I: GM-CSF Group (GG)27
Arm II: Salt & Soda Group (SS)25
Arm III: Salt & Soda Switched to GM-CSF (SG)27

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I: GM-CSF Group (GG)2.152.40Not reportedNot reportedNot reported
Arm II: Salt & Soda Group (SS)1.722.26Not reportedNot reportedNot reported
Arm III: Salt & Soda Switched to GM-CSF (SG)2.152.65Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.22
    p Value Comment
    0.22 (quadratic)
    statistical Comment
    Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.22
    p Value Comment
    0.22 (quadratic)
    statistical Comment
    Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.40
        value
        2.15
      2. group Id
        OG001
        spread
        2.26
        value
        1.72
      3. group Id
        OG002
        spread
        2.65
        value
        2.15
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      27
    units
    Participants
description
Severity and quality of pain was measured using a pain questionnaire developed for this study with total scores ranging from 0 (no pain) to 10 (most intense pain) with higher scores indicating a greater level of pain. The questionnaire was administered at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were combined to compute one mean to determine overall pain intensity score during the course of the study
dispersion Type
Standard Deviation
groups
  1. description
    Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    OG000
    title
    Arm I: GM-CSF Group (GG)
  2. description
    Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
    id
    OG001
    title
    Arm II: Salt & Soda Group (SS)
  3. description
    Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
    id
    OG002
    title
    Arm III: Salt & Soda Switched to GM-CSF (SG)
param Type
MEAN
population Description
Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons.
reporting Status
POSTED
time Frame
Up to 3 months
title
Comparison of Combined Mean Score on the Pain Questionnaire by Group
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice