Phase II Randomized Trial of Acupuncture-Like Transcutaneous Electrical Nerve Stimulation to Prevent Radiation-Induced Xerostomia in Head and Neck Cancer Patients.

Abstract

Current evidence indicates that acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) can provide sustained benefit for established radiation-induced xerostomia (RIX) symptoms. This is further being evaluated by comparing it with standard treatment (pilocarpine) in a randomized controlled trial. This report studies the potential effectiveness of xerostomia prevention using ALTENS delivered concomitantly with radiotherapy administered to head and neck cancer patients. Sixty patients were randomized to either the treatment group (n = 30) that received ALTENS daily with radiotherapy or the control group (n = 26) that had standard mouth care only. Stimulated and basal unstimulated whole saliva production (WSP) plus RIX symptoms visual analogue score (RIXVAS) were assessed at specific time points. Generalized linear models and generalized estimating equations were used for analysis. RIXVAS at 3 months follow-up after therapy completion was used as the primary study endpoint. The mean RIXVAS for the ALTENS intervention at 3 months was 39.8, which was not significantly different from the control arm value of 40.5. There were no statistically significant differences between the two groups for their mean RIXVAS and WSP at all assessment time points. In conclusion, there was no significant difference in mean WSP and RIXVAS between the two groups, so ALTENS is not recommended as a prophylactic intervention.