Int J Radiat Oncol Biol Phys. 2023 Mar 16:S0360-3016(23)00289-4. doi: 10.1016/j.ijrobp.2023.03.047. Online ahead of print.
PURPOSE: Radiotherapy-induced xerostomia (RIX) significantly affects quality of life in head and neck cancer (HNC) survivors. Neuro-electrostimulation of the salivary glands may safely increase natural salivation and reduce dry mouth symptoms.
METHODS AND MATERIALS: Multicentre double-masked randomised sham-controlled clinical trial to assess the long-term effects of a commercially available intra-oral neuro-electrostimulating device in lessening xerostomia symptoms, increasing salivary flow and improving quality of life in individuals with RIX. Using a computer-generated randomization list, participants were assigned (1:1) to an active intra-oral 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 VAS at 12 months. A number of secondary and exploratory outcomes were also assessed through validated measurements (sialometry and VAS) and quality of life questionnaires (EORTC QLQ-H&N35, OH-QoL16 and SF-36).
RESULTS: 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 sub-scale score of the EORTC QLQ-H&N35 in favour of the active intervention.
CONCLUSION: LEONIDAS-2 did not meet the primary and secondary outcomes.
FUNDING: NIHR Research for Patient Benefit Programme.