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NCT00656513 · OUTCOME

Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (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, 4, 6, 9 and 15 months from randomization

What was measured

Symptom 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 domain score is the average of all responses on a given domain and can range from 0 to 4, with higher scores indicating increased symptom burden. Change in symptom burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the symptom burden.

Analysis population: Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) 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 III67
ALTENS: Phase III63

Reported measurements

4-month Physical Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III52
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-0.750Not reported
ALTENS: Phase III-0.5Not reported-0.750Not reported
4-month Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III52
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.25Not reported-0.750Not reported
ALTENS: Phase III-0.375Not reported-10.125Not reported
4-month Personal/Psychological Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III52
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.25Not reported-0.50.25Not reported
ALTENS: Phase III-0.5Not reported-0.875-0.125Not reported
4-month Social Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III52
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0Not reported-0.670.33Not reported
ALTENS: Phase III-0.33Not reported-0.8350Not reported
6-month Physical Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III45
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-10Not reported
ALTENS: Phase III-0.5Not reported-10Not reported
6-month Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III45
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.25Not reported-0.50Not reported
ALTENS: Phase III-0.5Not reported-10Not reported
6-month Personal/Psychological Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III45
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.25Not reported-0.750Not reported
ALTENS: Phase III-0.5Not reported-1-0.25Not reported
6-month Social Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III45
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.33Not reported-0.670.66Not reported
ALTENS: Phase III-0.33Not reported-0.670Not reported
9-month Physical Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III53
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-1.250Not reported
ALTENS: Phase III-0.5Not reported-1-0.25Not reported
9-month Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III53
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.25Not reported-0.50Not reported
ALTENS: Phase III-0.5Not reported-10Not reported
9-month Personal/Psychological Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III53
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-10.25Not reported
ALTENS: Phase III-0.75Not reported-1-0.25Not reported
9-month Social Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III53
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.66Not reported-10.33Not reported
ALTENS: Phase III-0.33Not reported-0.670Not reported
15-month Physical Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-10Not reported
ALTENS: Phase III-0.75Not reported-1.25-0.25Not reported
15-month Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-10Not reported
ALTENS: Phase III-0.5Not reported-10Not reported
15-month Personal/Psychological Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III-0.5Not reported-10Not reported
ALTENS: Phase III-0.75Not reported-1.25-0.25Not reported
15-month Social Functioning

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III43
ALTENS: Phase III47
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0Not reported-10.33Not reported
ALTENS: Phase III-0.33Not reported-0.670Not 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
    0.35
    p Value Comment
    4-month Physical Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.78
    p Value Comment
    4 months Pain/Discomfort score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  3. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.12
    p Value Comment
    4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  4. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.28
    p Value Comment
    4-month Social Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  5. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.98
    p Value Comment
    6-month Physical Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  6. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.28
    p Value Comment
    6-month Pain/Discomfort score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  7. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.13
    p Value Comment
    6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  8. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.58
    p Value Comment
    6-month Social Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  9. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.88
    p Value Comment
    9-month Physical Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  10. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.09
    p Value Comment
    9-month Pain/Discomfort score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  11. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.49
    p Value Comment
    9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  12. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.45
    p Value Comment
    9-month Social Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.35
    p Value Comment
    4-month Physical Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.78
    p Value Comment
    4 months Pain/Discomfort score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  3. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.12
    p Value Comment
    4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  4. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.28
    p Value Comment
    4-month Social Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  5. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.98
    p Value Comment
    6-month Physical Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  6. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.28
    p Value Comment
    6-month Pain/Discomfort score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  7. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.13
    p Value Comment
    6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  8. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.58
    p Value Comment
    6-month Social Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  9. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.88
    p Value Comment
    9-month Physical Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  10. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.09
    p Value Comment
    9-month Pain/Discomfort score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  11. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.49
    p Value Comment
    9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
  12. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.45
    p Value Comment
    9-month Social Functioning score; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.75
        upper Limit
        0
        value
        -0.5
      2. group Id
        OG001
        lower Limit
        -0.75
        upper Limit
        0
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    4-month Physical Functioning
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.75
        upper Limit
        0
        value
        -0.25
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        0.125
        value
        -0.375
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    4-month Pain/Discomfort
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.5
        upper Limit
        0.25
        value
        -0.25
      2. group Id
        OG001
        lower Limit
        -0.875
        upper Limit
        -0.125
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    4-month Personal/Psychological Functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.67
        upper Limit
        0.33
        value
        0
      2. group Id
        OG001
        lower Limit
        -0.835
        upper Limit
        0
        value
        -0.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    4-month Social Functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        0
        value
        -0.5
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        0
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    6-month Physical Functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.5
        upper Limit
        0
        value
        -0.25
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        0
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    6-month Pain/Discomfort
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.75
        upper Limit
        0
        value
        -0.25
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        -0.25
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    6-month Personal/Psychological Functioning
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.67
        upper Limit
        0.66
        value
        -0.33
      2. group Id
        OG001
        lower Limit
        -0.67
        upper Limit
        0
        value
        -0.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    6-month Social Functioning
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.25
        upper Limit
        0
        value
        -0.5
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        -0.25
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    9-month Physical Functioning
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.5
        upper Limit
        0
        value
        -0.25
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        0
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    9-month Pain/Discomfort
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        0.25
        value
        -0.5
      2. group Id
        OG001
        lower Limit
        -1
        upper Limit
        -0.25
        value
        -0.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    9-month Personal/Psychological Functioning
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        0.33
        value
        -0.66
      2. group Id
        OG001
        lower Limit
        -0.67
        upper Limit
        0
        value
        -0.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    9-month Social Functioning
denoms
  1. counts
    1. group Id
      OG000
      value
      67
    2. group Id
      OG001
      value
      63
    units
    Participants
description
Symptom 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 domain score is the average of all responses on a given domain and can range from 0 to 4, with higher scores indicating increased symptom burden. Change in symptom burden is calculated by subtracting the baseline score from the 9-month score such that a negative change indicates an improvement of the symptom 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 patients with both baseline and respective follow-up (4,6, 9,15 months) XeQOLS scores.
reporting Status
POSTED
time Frame
Baseline, 4, 6, 9 and 15 months from randomization
title
Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice