Trial · NCT00656513
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
NCT00656513, Phase 2, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer. Trials, record NCT00656513. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00656513
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
- NCT number
- NCT00656513
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 196 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Head and Neck Cancer, Xerostomia
- Interventions
- Pilocarpine, ALTENS
- First posted
- 2008-04-11
- Last updated
- 2019-11-19
- Results first posted
- 2017-08-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II: Treatment Compliance (Number of Compliant Patients) | Randomization to 12 weeks | 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. |
| Primary | Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months | Baseline (randomization) and 9 months | 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. |
| Secondary | Phase II: Pecentage of Patients With Beneficial Treatment Response | Pre-treatment and 6 months from registration | 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. |
| Secondary | Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | Baseline, 4, 6, and 15 months from randomization | 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. |
| Secondary | Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III) | Baseline, 4, 6, 9 and 15 months from randomization | 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. |
| Secondary | Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III) | Baseline, 4, 6, 9 and 15 months from randomization | 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. |
| Secondary | Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III) | Pre-treatment to 4, 6, 9 and 15 months from randomization | 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. |
| Secondary | Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III | Baseline and 9 months from randomization. | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase II: Treatment Compliance (Number of Compliant Patients) | Randomization to 12 weeks | Eligible patients starting protocol treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months | Baseline (randomization) and 9 months | Eligible randomized patients with both baseline and 9 month XeQOLS scores | units on a scale | MEDIAN |
| SECONDARY | Phase II: Pecentage of Patients With Beneficial Treatment Response | Pre-treatment and 6 months from registration | Eligible patients who started treatment and have both baseline and 6-month XeQOLS scores | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | Baseline, 4, 6, and 15 months from randomization | Eligible patients with both baseline and respective follow-up (4,6,15 months) XeQOLS scores. | units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Symptom Burden at 4, 6, 9 and 15 Months (Phase III) | Baseline, 4, 6, 9 and 15 months from randomization | Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) XeQOLS scores. | units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Stimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III) | Baseline, 4, 6, 9 and 15 months from randomization | Eligible patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements. | ml/min | MEDIAN |
| SECONDARY | Change From Baseline in Unstimulated Whole Salivary Production (WSP) at 4, 6, 9 and 15 Months (Phase III) | Pre-treatment to 4, 6, 9 and 15 months from randomization | Eligible randomized patients with both baseline and respective follow-up (4,6, 9,15 months) WSP measurements. | ml/min | MEDIAN |
| SECONDARY | Quality of Life (QOL) as Measured by the University of Washington Head and Neck Questionnaire (UWHNSS) Phase III | Baseline and 9 months from randomization. | Eligible randomized patients with both baseline and 9-month UWHNSS total scores. | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase II: Treatment Compliance (Number of Compliant Patients) | ALTENS: Phase II | First Stage | 12 | Participants | |
| Phase II: Treatment Compliance (Number of Compliant Patients) | ALTENS: Phase II | Second Stage (Overall) | 44 | Participants | |
| Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months | Pilocarpine: Phase III | -0.27 | Inter-Quartile Range -1.06 to 0 | units on a scale | |
| Phase III: Change From Baseline in Overall Xerostomia Burden at 9 Months | ALTENS: Phase III | -0.53 | Inter-Quartile Range -0.87 to -0.2 | units on a scale | |
| Phase II: Pecentage of Patients With Beneficial Treatment Response | ALTENS: Phase II | 85.7 | 95% Confidence Interval 84.9 to 86.5 | percentage of participants | |
| Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | Pilocarpine: Phase III | 4 months | -0.27 | Inter-Quartile Range -0.6 to 0 | units on a scale |
| Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | ALTENS: Phase III | 4 months | -0.47 | Inter-Quartile Range -0.8 to -0.13 | units on a scale |
| Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | Pilocarpine: Phase III | 6 months | -0.33 | Inter-Quartile Range -0.73 to -0.2 | units on a scale |
| Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | ALTENS: Phase III | 6 months | -0.4 | Inter-Quartile Range -0.87 to -0.14 | units on a scale |
| Change From Baseline in Overall Xerostomia Burden at 4, 6, and 15 Months (Phase III) | Pilocarpine: Phase III | 15 months | -0.47 | Inter-Quartile Range -0.87 to -0.07 | units on a scale |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ALTENS: Phase II | 48 | |
| Overall Study | STARTED | Pilocarpine: Phase III | 73 | |
| Overall Study | STARTED | ALTENS: Phase III | 75 | |
| Overall Study | COMPLETED | ALTENS: Phase II | 44 | |
| Overall Study | COMPLETED | Pilocarpine: Phase III | 43 | |
| Overall Study | COMPLETED | ALTENS: Phase III | 53 | |
| Overall Study | NOT COMPLETED | ALTENS: Phase II | 4 | |
| Overall Study | NOT COMPLETED | Pilocarpine: Phase III | 30 | |
| Overall Study | NOT COMPLETED | ALTENS: Phase III | 22 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tinnitus | Ear and labyrinth disorders | ALTENS: Phase II | 0 | 47 | |
| other | Tinnitus | Ear and labyrinth disorders | Pilocarpine: Phase III | 4 | 73 | |
| other | Tinnitus | Ear and labyrinth disorders | ALTENS: Phase III | 2 | 72 | |
| other | Vision blurred | Eye disorders | ALTENS: Phase II | 0 | 47 | |
| other | Vision blurred | Eye disorders | Pilocarpine: Phase III | 5 | 73 | |
| other | Vision blurred | Eye disorders | ALTENS: Phase III | 0 | 72 | |
| other | Constipation | Gastrointestinal disorders | ALTENS: Phase II | 0 | 47 | |
| other | Constipation | Gastrointestinal disorders | Pilocarpine: Phase III | 4 | 73 | |
| other | Constipation | Gastrointestinal disorders | ALTENS: Phase III | 1 | 72 | |
| other | Diarrhea | Gastrointestinal disorders | ALTENS: Phase II | 0 | 47 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALTENS: Phase II | ||
| Total, all-cause mortality | Pilocarpine: Phase III | ||
| Total, all-cause mortality | ALTENS: Phase III | ||
| Total, other adverse events | ALTENS: Phase II | 7 | 47 |
| Total, other adverse events | Pilocarpine: Phase III | 51 | 73 |
| Total, other adverse events | ALTENS: Phase III | 27 | 72 |
| Total, serious adverse events | ALTENS: Phase II | 1 | 47 |
| Total, serious adverse events | Pilocarpine: Phase III | 0 | 73 |
| Total, serious adverse events | ALTENS: Phase III | 1 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22252927 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00656513
GET https://conductscience.org/api/trials/v1/NCT00656513/results?page=2