Mercadante, V; (2016) The LEONIDAS-2 study: Long-term Evaluation of the sffectiveness Of a Novel Intra-oral electro-stimulator for the treatment of raDiotherapy-ASsociated xerostomia. Doctoral thesis , UCL (University College London).

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Abstract

Head and neck cancer is the 7th most common cancer worldwide and the 7th leading cause of cancer-related death. The vast majority of head and neck cancers are diagnosed at advanced stage, which is characterised by large volume disease and locoregional metastases. The overall 5-year survival rate of head and neck cancer is 50%, although most patients with advanced stage cancers die within few years from diagnosis because of relapsing incurable disease. Head and neck cancer patients are often managed with radiotherapy, either as main treatment modality or in association with chemotherapy and surgery. Radiotherapy can cause acute and long-term complication, of which chronic xerostomia is one of the most debilitating. Current treatment of radiotherapy-associated xerostomia encompasses systemic and local therapeutic strategies. None of them, however, represent the ideal treatment in terms of efficacy and safety. Neuro-stimulation of salivary glands via electrical stimulation was initially introduced 30 years ago. It is suggested to provide the benefit of increasing natural salivation with no relevant adverse side effects. Studies using the first generation of electrostimulating devices suggested clinical significant benefit in a small cohort of individuals with radiotherapy-associated xerostomia. More recently, the use of a second-generation intra-oral device, as well as facial transcutaneous nerve stimulation, has been associated with an increase in saliva production and reduction in xerostomia symptoms. Although promising, current data do not provide robust evidence and highlight the need of further and better designed clinical trials in order to investigate the real benefit of salivary electrostimulation in the post-radiotherapy setting. We have performed a double-blind randomised clinical trial (The LEONIDAS-2 study) to assess the long-term efficacy of the second generation intraoral electrostimulating device in lessening xerostomia symptoms, increasing salivary gland function and improving quality of life in individuals with radiotherapy-associated xerostomia. The clinical trial took place between January 2012 and January 2015 at the University College London Hospital and Bradford Royal Infirmary (UK). Eighty-four participants were randomised to use an active electrostimulating device (providing mechanical and electrical stimulation) or a sham device (providing mechanical but not electrical stimulation) for 12 months. Randomisation was by computer-generation and analyses were performed on an intention-to-treat basis. Sixty-eight participants completed the trial. At 12 months an improvement in xerostomia symptoms (VAS) compared to baseline was observed, with no significant difference in means between the active and sham group. Salivary flow rate, measured through sialometry, was higher in the active group but the difference between the two groups was not statistically significant. At 12 months there was an improvement in quality of life, with no significant difference between the active and the control groups. The LEONIDAS-2 clinical trial showed that salivary electrostimulation through the second generation intra-oral electrostimulating device is safe but not more effective than mechanical stimulation in relieving dry mouth symptoms, increasing salivary function or improving quality of life in patients with radiotherapy-associated xerostomia.

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