BACKGROUND: In this phase 2 component of a multi-institutional, phase 2/3, randomized trial, the authors assessed the feasibility and preliminary efficacy of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in reducing radiation-induced @entity2133 . METHODS: @entity1 with @entity135 who were 3 to 24 months from completing radiotherapy with or without chemotherapy (RT    C) and who were experiencing @entity2133 symptoms with basal whole saliva production >= 0.1 mL per minute and were without recurrence were eligible. @entity1 received twice weekly ALTENS sessions (24 sessions over 12 weeks) using a proprietary electrical stimulation unit. The primary study objective was to assess the feasibility of ALTENS treatment. @entity1 were considered compliant if 19 of 24 ALTENS sessions were delivered, and the targeted compliance rate was 85%. Secondary objectives measured treatment-related @entity137 and the effect of ALTENS on overall radiation-induced @entity2133 burden using the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS). RESULTS: Of 48 accrued @entity1 , 47 were evaluable. The median age was 60 years, 84% of @entity1 were @entity1 , 70% completed RT    C for >12 months, and 21% had previously received @entity2134 . Thirty-four @entity1 completed all 24 ALTENS sessions, 9 @entity1 completed 20 to 23 sessions, and 1 @entity1 completed 19 sessions, representing a 94% total compliance rate. Six-month XeQOLS scores were available for 35 @entity1 and indicated that 30 @entity1 (86%) achieved a positive treatment response with a mean    standard deviation reduction of 35.9%    36.1%. Five @entity1 developed grade 1 or 2 gastrointestinal @entity137 , and 1 had a grade 1 @entity158 event. CONCLUSIONS: The current results indicated that ALTENS treatment for radiation-induced @entity2133 can be delivered uniformly in a cooperative, multicenter setting and produces possible beneficial treatment response. Given these results, the phase 3 component of this study was initiated.

Phase 2 results from Radiation Therapy Oncology Group Study 0537: a phase 2/3 study comparing acupuncture-like transcutaneous electrical nerve stimulation versus @entity2134 in treating early radiation-induced XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'men'] @entity135 :: ('MESH:D006258', 'Disease') :: ['cancer of the head and neck'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity2133 :: ('MESH:D014987', 'Disease') :: ['xerostomia'] @entity2134 :: ('MESH:D010862', 'Chemical') :: ['pilocarpine'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain']
@entity2133 :: (MESH:D014987,Disease) :: ['xerostomia']
