NCT00656513 · OUTCOME

Change From Baseline in Overall Xerostomia Burden at 4, 6, 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, and 15 months from randomization

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 patients with both baseline and respective follow-up (4,6,15 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

Group	Source count
Pilocarpine: Phase III	67
ALTENS: Phase III	63

Reported measurements

4 months

Analysis denominator · Participants

Group	Source count
Pilocarpine: Phase III	67
ALTENS: Phase III	52

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Pilocarpine: Phase III	-0.27	Not reported	-0.6	0	Not reported
ALTENS: Phase III	-0.47	Not reported	-0.8	-0.13	Not reported

6 months

Analysis denominator · Participants

Group	Source count
Pilocarpine: Phase III	45
ALTENS: Phase III	47

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Pilocarpine: Phase III	-0.33	Not reported	-0.73	-0.2	Not reported
ALTENS: Phase III	-0.4	Not reported	-0.87	-0.14	Not reported

15 months

Analysis denominator · Participants

Group	Source count
Pilocarpine: Phase III	67
ALTENS: Phase III	47

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Pilocarpine: Phase III	-0.47	Not reported	-0.87	-0.07	Not reported
ALTENS: Phase III	-0.6	Not reported	-1	-0.2	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.11
p Value Comment
Two-sided test of values at 4 months.
statistical Method
Wilcoxon (Mann-Whitney)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.31
p Value Comment
Two-sided test of values at 6 months.
statistical Method
Wilcoxon (Mann-Whitney)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.21
p Value Comment
Two-sided test of values at 15 months.
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.11
p Value Comment
Two-sided test of values at 4 months.
statistical Method
Wilcoxon (Mann-Whitney)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.31
p Value Comment
Two-sided test of values at 6 months.
statistical Method
Wilcoxon (Mann-Whitney)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.21
p Value Comment
Two-sided test of values at 15 months.
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
lower Limit
-0.6
upper Limit
0
value
-0.27
group Id
OG001
lower Limit
-0.8
upper Limit
-0.13
value
-0.47
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
52
units
Participants
title
4 months
categories
measurements
group Id
OG000
lower Limit
-0.73
upper Limit
-0.2
value
-0.33
group Id
OG001
lower Limit
-0.87
upper Limit
-0.14
value
-0.4
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
47
units
Participants
title
6 months
categories
measurements
group Id
OG000
lower Limit
-0.87
upper Limit
-0.07
value
-0.47
group Id
OG001
lower Limit
-1
upper Limit
-0.2
value
-0.6
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
47
units
Participants
title
15 months

denoms

counts
group Id
OG000
value
67
group Id
OG001
value
63
units
Participants

description

dispersion Type

Inter-Quartile Range

groups

description
5mg pilocarpine by mouth 3 times a day for 12 weeks
id
OG000
title
Pilocarpine: Phase III
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 (4,6,15 months) XeQOLS scores.

reporting Status

POSTED

time Frame

Baseline, 4, 6, and 15 months from randomization

title

Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice