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NCT00656513 · OUTCOME

Change From Baseline in Unstimulated Whole Salivary Production (WSP) 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
ml/min
Interval / dispersion
Inter-Quartile Range
Time frame
Pre-treatment to 4, 6, 9 and 15 months from randomization

What was measured

Basal whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.

Analysis population: Eligible randomized patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.

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 III73
ALTENS: Phase III73

Reported measurements

4 months

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III49
ALTENS: Phase III63
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0Not reported-0.30.29Not reported
ALTENS: Phase III0Not reported-0.280.38Not reported
6 months

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III47
ALTENS: Phase III58
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0Not reported-0.30.7Not reported
ALTENS: Phase III0.02Not reported-0.320.46Not reported
9 months

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III46
ALTENS: Phase III63
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0.056Not reported-0.10.9Not reported
ALTENS: Phase III0.04Not reported-0.20.587Not reported
15 months

Analysis denominator · Participants

GroupSource count
Pilocarpine: Phase III49
ALTENS: Phase III57
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0.13Not reported00.9Not reported
ALTENS: Phase III0.192Not reported-0.20.8Not 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
    0.54
    p Value Comment
    4-months; 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
    0.99
    p Value Comment
    6-months; 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
    0.56
    p Value Comment
    6-months; 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
    0.58
    p Value Comment
    6-months; 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
    0.54
    p Value Comment
    4-months; 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
    0.99
    p Value Comment
    6-months; 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
    0.56
    p Value Comment
    6-months; 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
    0.58
    p Value Comment
    6-months; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.3
        upper Limit
        0.29
        value
        0
      2. group Id
        OG001
        lower Limit
        -0.28
        upper Limit
        0.38
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        63
      units
      Participants
    title
    4 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.3
        upper Limit
        0.7
        value
        0
      2. group Id
        OG001
        lower Limit
        -0.32
        upper Limit
        0.46
        value
        0.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        58
      units
      Participants
    title
    6 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.1
        upper Limit
        0.9
        value
        0.056
      2. group Id
        OG001
        lower Limit
        -0.2
        upper Limit
        0.587
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        63
      units
      Participants
    title
    9 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.9
        value
        0.13
      2. group Id
        OG001
        lower Limit
        -0.2
        upper Limit
        0.8
        value
        0.192
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    15 months
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Basal whole salivary production (WSP) was measured by expectoration weight, with one gram of saliva produced considered as one ml of saliva. WSP is expressed in ml/min calculated by dividing the measured weight or volume of WSP by five. Procedure: Patients refrain from eating, drinking, and smoking at least two hours prior to each measurement. For each measurement, patients are asked to expectorate continuously into a pre-weighed dry plastic container over a 5-minute period without swallowing. The collected saliva with the plastic container will be weighed (total weight) immediately after each collection. The total weight minus the weight of the container is the weight or volume of whole saliva collected.
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 respective follow-up (4,6, 9,15 months) WSP measurements.
reporting Status
POSTED
time Frame
Pre-treatment to 4, 6, 9 and 15 months from randomization
title
Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)
type
SECONDARY
unit Of Measure
ml/min

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Preserved source evidence · Not medical advice