Salivary Electrostimulation in the Treatment of Radiation Therapy–Induced Xerostomia (LEONIDAS-2): A Multicenter, Randomized, Double-Masked, Sham-Controlled, Phase 3 Trial

• DOI: 10.1016/j.ijrobp.2023.03.047
• Publication Date: 2023-03-17T01:47:06Z
• Authors: Valeria Mercadante; Arwa Al Hamad; James McCaul; Christopher Nutting; Kevin Harrington; Dawn Carnell; Teresa Guerrero U...; Nicholas Kalavrezos; Julie A. Barber; Stephen R. Porter; Stefano Fedele
• Keywords: Head and Neck Neoplasms; Quality of Life; Humans; Electric Stimulation Therapy; Salivation; Radiation Injuries; Xerostomia; Salivary Glands; 3. Good health

Radiation therapy-induced xerostomia significantly affects quality of life in head and neck cancer survivors. Neuro-electrostimulation of the salivary glands may safely increase natural salivation and reduce dry mouth symptoms.This multicenter, double-masked, randomized, sham-controlled clinical trial assessed the long-term effects of a commercially available intraoral neuro-electrostimulating device in lessening xerostomia symptoms, increasing salivary flow, and improving quality of life in individuals with radiation therapy-induced xerostomia. Using a computer-generated randomization list, participants were assigned (1:1) to an active intraoral custom-made removable electrostimulating device or a sham device to be used for 12 months. The primary outcome was the proportion of patients reporting a 30% improvement on the xerostomia visual analog scale at 12 months. A number of secondary and exploratory outcomes were also assessed through validated measurements (sialometry and visual analog scale) and quality-of-life questionnaires (EORTC QLQ-H&N35, OH-QoL16, and SF-36).As per protocol, 86 participants were recruited. Intention-to-treat analyses showed no statistical evidence of a difference between the study groups with respect to the primary outcome or for any of the secondary clinical or quality-of-life outcomes. Exploratory analyses showed a statistically significant difference in the changes over time of the dry mouth subscale score of the EORTC QLQ-H&N35 in favor of the active intervention.LEONIDAS-2 did not meet the primary and secondary outcomes.