{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.9","upperLimit":"86.5","value":"85.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"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.","dispersionType":"95% Confidence Interval","groups":[{"description":"Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) twice weekly for 12 weeks via a Codetron unit","id":"OG000","title":"ALTENS: Phase II"}],"paramType":"NUMBER","populationDescription":"Eligible patients who started treatment and have both baseline and 6-month XeQOLS scores","reportingStatus":"POSTED","timeFrame":"Pre-treatment and 6 months from registration","title":"Phase II: Pecentage of Patients With Beneficial Treatment Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}