Skip to content
← Full study record

NCT00656513 · OUTCOME

Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III

Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer · Source last updated 2019-11-19

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

Measure
MEDIAN
Unit
units on a scale
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline and 9 months from randomization.

What was measured

The UWHNSS includes ten categories-pain, disfigurement, activity, recreation/entertainment, employment, eating, saliva, taste, speech, mucus/phlegm. Patient scores on the UWHNSS range from 0 to 100 with higher scores indicating declining quality of life. Change in total score was calculated by subtracting baseline from follow-up , thus a positive change score indicates a worsening while a negative change score indicates an improvement.

Analysis population: Eligible randomized patients with both baseline and 9-month UWHNSS total scores.

Groups in this outcome

Pilocarpine: Phase III

5mg pilocarpine by mouth 3 times a day for 12 weeks

ALTENS: Phase III

Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit

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

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III51

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-3.64Not reported-9.091.82Not reported
ALTENS: Phase III-7.27Not reported-12.73-1.81Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.14
    p Value Comment
    Two-sided test, significance level 0.05
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.14
    p Value Comment
    Two-sided test, significance level 0.05
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -9.09
        upper Limit
        1.82
        value
        -3.64
      2. group Id
        OG001
        lower Limit
        -12.73
        upper Limit
        -1.81
        value
        -7.27
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      51
    units
    Participants
description
The UWHNSS includes ten categories-pain, disfigurement, activity, recreation/entertainment, employment, eating, saliva, taste, speech, mucus/phlegm. Patient scores on the UWHNSS range from 0 to 100 with higher scores indicating declining quality of life. Change in total score was calculated by subtracting baseline from follow-up , thus a positive change score indicates a worsening while a negative change score indicates an improvement.
dispersion Type
Inter-Quartile Range
groups
  1. description
    5mg pilocarpine by mouth 3 times a day for 12 weeks
    id
    OG000
    title
    Pilocarpine: Phase III
  2. description
    Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
    id
    OG001
    title
    ALTENS: Phase III
param Type
MEDIAN
population Description
Eligible randomized patients with both baseline and 9-month UWHNSS total scores.
reporting Status
POSTED
time Frame
Baseline and 9 months from randomization.
title
Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice