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Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00656513
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Head and Neck Cancer
Xerostomia
Interventions Drug: Pilocarpine
Procedure: ALTENS
Enrollment 196

Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALTENS: Phase II Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit 5mg pilocarpine by mouth 3 times a day for 12 weeks Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Period Title: Overall Study
Started 48 73 75
Completed 44 [1] 43 [1] 53 [1]
Not Completed 4 30 22
Reason Not Completed
Protocol Violation             1             0             2
Withdrawal by Subject             0             11             4
Death             0             0             1
Missing data             0             11             9
Incomplete treatment             3             0             0
Treatment completed outside of timeframe             0             3             1
Missing baseline form             0             5             5
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title ALTENS: Phase II Pilocarpine: Phase III ALTENS: Phase III Total
Hide Arm/Group Description Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit 5mg pilocarpine by mouth 3 times a day for 12 weeks Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit Total of all reporting groups
Overall Number of Baseline Participants 47 73 73 193
Hide Baseline Analysis Population Description
Eligible patients (i.e. without protocol violation)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants 73 participants 73 participants 193 participants
60
(24 to 80)
59
(29 to 78)
58
(42 to 83)
58
(24 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 73 participants 73 participants 193 participants
Female
7
  14.9%
10
  13.7%
11
  15.1%
28
  14.5%
Male
40
  85.1%
63
  86.3%
62
  84.9%
165
  85.5%
1.Primary Outcome
Title Phase II: Treatment Compliance (Number of Compliant Patients)
Hide Description Patients completing at least 19 out of 24 ALTENS therapy sessions were categorized as compliant. Fleming’s two-stage was used, assuming a successful target compliance rate of 80%, statistical power of 0.87, and a type I error rate of 0.13. If fewer than 9 of the first 13 patients were compliant, then treatment delivery will be deemed not feasible. If there were between 9-12 compliant patients, the second stage analysis would be required to determine feasibility of treatment delivery. If all 13 patients are compliant, treatment delivery will immediately be deemed feasible. The second stage analysis required at least 31 compliant out of 39 overall patients for the treatment delivery to be deemed feasible.
Time Frame Randomization to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients starting protocol treatment
Arm/Group Title ALTENS: Phase II
Hide Arm/Group Description:
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
First Stage Number Analyzed 13 participants
12
  92.3%
Second Stage (Overall) Number Analyzed 47 participants
44
  93.6%
2.Primary Outcome
Title Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months
Hide 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.
Time Frame Baseline (randomization) and 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized patients with both baseline and 9 month XeQOLS scores
Arm/Group Title Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description:
5mg pilocarpine by mouth 3 times a day for 12 weeks
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 43 53
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-0.27
(-1.06 to 0)
-0.53
(-0.87 to -0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments 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%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Phase II: Pecentage of Patients With Beneficial Treatment Response
Hide Description This secondary objective was to evaluate the effect of ALTENS treatment on overall radiation-induced xerostomia burden by looking at treatment response. Treatment response was determined by a reduction of at least 20% from baseline to 6 months in 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. Higher scores indicate increased xerostomia burden. This scale has high reproducibility and sensitivity. For the first and second stage analyses, 4 and 10 patients, respectively, must respond to treatment in order to proceed to the phase III component.
Time Frame Pre-treatment and 6 months from registration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started treatment and have both baseline and 6-month XeQOLS scores
Arm/Group Title ALTENS: Phase II
Hide Arm/Group Description:
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.7
(84.9 to 86.5)
4.Secondary Outcome
Title Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III)
Hide 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.
Time Frame Baseline, 4, 6, and 15 months from randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both baseline and respective follow-up (4,6,15 months) XeQOLS scores.
Arm/Group Title Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description:
5mg pilocarpine by mouth 3 times a day for 12 weeks
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 67 63
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4 months Number Analyzed 67 participants 52 participants
-0.27
(-0.6 to 0)
-0.47
(-0.8 to -0.13)
6 months Number Analyzed 45 participants 47 participants
-0.33
(-0.73 to -0.2)
-0.4
(-0.87 to -0.14)
15 months Number Analyzed 67 participants 47 participants
-0.47
(-0.87 to -0.07)
-0.6
(-1 to -0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments Two-sided test of values at 4 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments Two-sided test of values at 6 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments Two-sided test of values at 15 months.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III)
Time Frame Baseline, 4, 6, 9 and 15 months from randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) XeQOLS scores.
Arm/Group Title Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description:
5mg pilocarpine by mouth 3 times a day for 12 weeks
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 67 63
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4-month Physical Functioning Number Analyzed 43 participants 52 participants
-0.5
(-0.75 to 0)
-0.5
(-0.75 to 0)
4-month Pain/Discomfort Number Analyzed 43 participants 52 participants
-0.25
(-0.75 to 0)
-0.375
(-1 to 0.125)
4-month Personal/Psychological Functioning Number Analyzed 43 participants 52 participants
-0.25
(-0.5 to 0.25)
-0.5
(-0.875 to -0.125)
4-month Social Functioning Number Analyzed 43 participants 52 participants
0
(-0.67 to 0.33)
-0.33
(-0.835 to 0)
6-month Physical Functioning Number Analyzed 45 participants 47 participants
-0.5
(-1 to 0)
-0.5
(-1 to 0)
6-month Pain/Discomfort Number Analyzed 45 participants 47 participants
-0.25
(-0.5 to 0)
-0.5
(-1 to 0)
6-month Personal/Psychological Functioning Number Analyzed 45 participants 47 participants
-0.25
(-0.75 to 0)
-0.5
(-1 to -0.25)
6-month Social Functioning Number Analyzed 45 participants 47 participants
-0.33
(-0.67 to 0.66)
-0.33
(-0.67 to 0)
9-month Physical Functioning Number Analyzed 43 participants 53 participants
-0.5
(-1.25 to 0)
-0.5
(-1 to -0.25)
9-month Pain/Discomfort Number Analyzed 43 participants 53 participants
-0.25
(-0.5 to 0)
-0.5
(-1 to 0)
9-month Personal/Psychological Functioning Number Analyzed 43 participants 53 participants
-0.5
(-1 to 0.25)
-0.75
(-1 to -0.25)
9-month Social Functioning Number Analyzed 43 participants 53 participants
-0.66
(-1 to 0.33)
-0.33
(-0.67 to 0)
15-month Physical Functioning Number Analyzed 43 participants 47 participants
-0.5
(-1 to 0)
-0.75
(-1.25 to -0.25)
15-month Pain/Discomfort Number Analyzed 43 participants 47 participants
-0.5
(-1 to 0)
-0.5
(-1 to 0)
15-month Personal/Psychological Functioning Number Analyzed 43 participants 47 participants
-0.5
(-1 to 0)
-0.75
(-1.25 to -0.25)
15-month Social Functioning Number Analyzed 43 participants 47 participants
0
(-1 to 0.33)
-0.33
(-0.67 to 0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments 4-month Physical Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments 4 months Pain/Discomfort score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments 4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments 4-month Social Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments 6-month Physical Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments 6-month Pain/Discomfort score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments 6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments 6-month Social Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments 9-month Physical Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments 9-month Pain/Discomfort score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments 9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments 9-month Social Functioning score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments 15-month Physical Functioning; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments 15-month Pain/Discomfort; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments 15-month Personal/Psychological Functioning; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments 15-month Social Functioning; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)
Hide 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.
Time Frame Baseline, 4, 6, 9 and 15 months from randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.
Arm/Group Title Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description:
5mg pilocarpine by mouth 3 times a day for 12 weeks
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 73 73
Median (Inter-Quartile Range)
Unit of Measure: ml/min
4 months
0.03
(-0.12 to 1.4)
0.2
(-0.2 to 0.9)
6 months
0.2
(-0.27 to 1.33)
0.40
(-0.3 to 1.07)
9 months
0.99
(0 to 1.9)
0.60
(-0.17 to 1.44)
15 months
0.3
(-0.3 to 1.7)
0.20
(-0.13 to 2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments 4-month score; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments 6-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments 9-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments 15-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III)
Hide 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.
Time Frame Pre-treatment to 4, 6, 9 and 15 months from randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements.
Arm/Group Title Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description:
5mg pilocarpine by mouth 3 times a day for 12 weeks
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 73 73
Median (Inter-Quartile Range)
Unit of Measure: ml/min
4 months Number Analyzed 49 participants 63 participants
0
(-0.3 to 0.29)
0
(-0.28 to 0.38)
6 months Number Analyzed 47 participants 58 participants
0
(-0.3 to 0.7)
0.02
(-0.32 to 0.46)
9 months Number Analyzed 46 participants 63 participants
0.056
(-0.1 to 0.9)
0.04
(-0.2 to 0.587)
15 months Number Analyzed 49 participants 57 participants
0.13
(0 to 0.9)
0.192
(-0.2 to 0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments 4-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments 6-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments 6-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments 6-months; two-sided test, significance level 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III
Hide Description The UWHNSS includes ten categories—pain, disfigurement, activity, recreation/entertainment, employment, eating, saliva, taste, speech, mucus/phlegm. Patient scores on the UWHNSS range from 0 to 100 with higher scores indicating declining quality of life. Change in total score was calculated by subtracting baseline from follow-up , thus a positive change score indicates a worsening while a negative change score indicates an improvement.
Time Frame Baseline and 9 months from randomization.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible randomized patients with both baseline and 9-month UWHNSS total scores.
Arm/Group Title Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description:
5mg pilocarpine by mouth 3 times a day for 12 weeks
Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
Overall Number of Participants Analyzed 43 51
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-3.64
(-9.09 to 1.82)
-7.27
(-12.73 to -1.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pilocarpine: Phase III, ALTENS: Phase III
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments Two-sided test, significance level 0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are reported for all eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title ALTENS: Phase II Pilocarpine: Phase III ALTENS: Phase III
Hide Arm/Group Description Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit 5mg pilocarpine by mouth 3 times a day for 12 weeks Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit
All-Cause Mortality
ALTENS: Phase II Pilocarpine: Phase III ALTENS: Phase III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ALTENS: Phase II Pilocarpine: Phase III ALTENS: Phase III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/47 (2.13%)   0/73 (0.00%)   1/72 (1.39%) 
Gastrointestinal disorders       
Gastrointestinal disorder * 1  1/47 (2.13%)  0/73 (0.00%)  0/72 (0.00%) 
Infections and infestations       
Appendicitis perforated * 1  0/47 (0.00%)  0/73 (0.00%)  1/72 (1.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALTENS: Phase II Pilocarpine: Phase III ALTENS: Phase III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/47 (14.89%)   51/73 (69.86%)   27/72 (37.50%) 
Ear and labyrinth disorders       
Tinnitus * 1  0/47 (0.00%)  4/73 (5.48%)  2/72 (2.78%) 
Eye disorders       
Vision blurred * 1  0/47 (0.00%)  5/73 (6.85%)  0/72 (0.00%) 
Gastrointestinal disorders       
Constipation * 1  0/47 (0.00%)  4/73 (5.48%)  1/72 (1.39%) 
Diarrhea * 1  0/47 (0.00%)  5/73 (6.85%)  1/72 (1.39%) 
Dry mouth * 1  5/47 (10.64%)  22/73 (30.14%)  18/72 (25.00%) 
Dysphagia * 1  1/47 (2.13%)  10/73 (13.70%)  9/72 (12.50%) 
General disorders       
Chills * 1  0/47 (0.00%)  5/73 (6.85%)  0/72 (0.00%) 
Fatigue * 1  1/47 (2.13%)  7/73 (9.59%)  6/72 (8.33%) 
Localized edema [head and neck] * 1  0/47 (0.00%)  1/73 (1.37%)  4/72 (5.56%) 
Musculoskeletal and connective tissue disorders       
Neck pain * 1  0/47 (0.00%)  3/73 (4.11%)  4/72 (5.56%) 
Nervous system disorders       
Dizziness * 1  0/47 (0.00%)  5/73 (6.85%)  3/72 (4.17%) 
Headache * 1  0/47 (0.00%)  14/73 (19.18%)  2/72 (2.78%) 
Taste alteration * 1  1/47 (2.13%)  5/73 (6.85%)  4/72 (5.56%) 
Psychiatric disorders       
Insomnia * 1  0/47 (0.00%)  4/73 (5.48%)  2/72 (2.78%) 
Renal and urinary disorders       
Urinary frequency * 1  0/47 (0.00%)  5/73 (6.85%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis * 1  0/47 (0.00%)  8/73 (10.96%)  2/72 (2.78%) 
Skin and subcutaneous tissue disorders       
Skin induration * 1  0/47 (0.00%)  3/73 (4.11%)  6/72 (8.33%) 
Sweating * 1  0/47 (0.00%)  24/73 (32.88%)  0/72 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00656513     History of Changes
Other Study ID Numbers: RTOG-0537
CDR0000592644
First Submitted: April 10, 2008
First Posted: April 11, 2008
Results First Submitted: June 22, 2017
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017