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NCT00656513 · OUTCOME

Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months

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 (randomization) and 9 months

What was measured

Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.

Analysis population: Eligible randomized patients with both baseline and 9 month XeQOLS 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 III53

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.27Not reported-1.060Not reported
ALTENS: Phase III-0.53Not reported-0.87-0.2Not reported

Source statistical analyses

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

  1. group Description
    An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.45
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Description
    An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.45
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.06
        upper Limit
        0
        value
        -0.27
      2. group Id
        OG001
        lower Limit
        -0.87
        upper Limit
        -0.2
        value
        -0.53
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      53
    units
    Participants
description
Xerostomia burden is measured by the University of Michigan Xerostomia Related Quality of Life Scale (XeQOLS). The XeQOLS is a validated patient-reported 15-item assessment scale with 4 domains: physical functioning,pain/discomfort, personal/psychologic functioning, and social functioning.The score is the average of all responses of all domains and can range from 0 to 4, with higher scores indicating increased xerostomia burden. Change in xerostomia burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the xerostomia burden.
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 XeQOLS scores
reporting Status
POSTED
time Frame
Baseline (randomization) and 9 months
title
Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months
type
PRIMARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice