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NCT02062632 · OUTCOME

Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment

Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy · Source last updated 2019-10-01

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

Measure
NUMBER
Unit
units on a scale
Interval / dispersion
Not reported
Time frame
Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1

What was measured

Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.

Analysis population: 5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.

Groups in this outcome

Placebo

Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.

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

Analysis denominator · Participants

GroupSource count
Placebo3

Reported measurements

Patient #1
Values in units on a scale · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo-1.6Not reportedNot reportedNot reportedNot reported
Patient #2
Values in units on a scale · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Patient #3
Values in units on a scale · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PlaceboNANot reportedNot reportedNot reportedPatient did not report a baseline pain score, so an AUC adjusted for baseline could not be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        -1.6
    title
    Patient #1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Patient #2
  3. categories
    1. measurements
      1. comment
        Patient did not report a baseline pain score, so an AUC adjusted for baseline could not be calculated.
        group Id
        OG000
        value
        NA
    title
    Patient #3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.
groups
  1. description
    Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
    id
    OG000
    title
    Placebo
param Type
NUMBER
population Description
5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.
reporting Status
POSTED
time Frame
Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1
title
Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment
type
PRIMARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice