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NCT00656513 · OUTCOME

Change From Baseline in Stimulated 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
Baseline, 4, 6, 9 and 15 months from randomization

What was measured

Stimulated (citric acid primed) 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. Stimulation is elicited by asking patients to rinse 5 ml of 2% citric acid solution in the mouth for 15 seconds and then completely expectorating the citric acid. 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 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
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0.03Not reported-0.121.4Not reported
ALTENS: Phase III0.2Not reported-0.20.9Not reported
6 months
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0.2Not reported-0.271.33Not reported
ALTENS: Phase III0.40Not reported-0.31.07Not reported
9 months
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0.99Not reported01.9Not reported
ALTENS: Phase III0.60Not reported-0.171.44Not reported
15 months
Values in ml/min · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pilocarpine: Phase III0.3Not reported-0.31.7Not reported
ALTENS: Phase III0.20Not reported-0.132Not 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
    0.97
    p Value Comment
    4-month 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
    0.83
    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
    0.28
    p Value Comment
    9-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
    0.89
    p Value Comment
    15-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
    0.97
    p Value Comment
    4-month 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
    0.83
    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
    0.28
    p Value Comment
    9-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
    0.89
    p Value Comment
    15-months; two-sided test, significance level 0.05
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.12
        upper Limit
        1.4
        value
        0.03
      2. group Id
        OG001
        lower Limit
        -0.2
        upper Limit
        0.9
        value
        0.2
    title
    4 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.27
        upper Limit
        1.33
        value
        0.2
      2. group Id
        OG001
        lower Limit
        -0.3
        upper Limit
        1.07
        value
        0.40
    title
    6 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        1.9
        value
        0.99
      2. group Id
        OG001
        lower Limit
        -0.17
        upper Limit
        1.44
        value
        0.60
    title
    9 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.3
        upper Limit
        1.7
        value
        0.3
      2. group Id
        OG001
        lower Limit
        -0.13
        upper Limit
        2
        value
        0.20
    title
    15 months
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Stimulated (citric acid primed) 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. Stimulation is elicited by asking patients to rinse 5 ml of 2% citric acid solution in the mouth for 15 seconds and then completely expectorating the citric acid. 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 patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.
reporting Status
POSTED
time Frame
Baseline, 4, 6, 9 and 15 months from randomization
title
Change From Baseline in Stimulated 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