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Salivary electrostimulation in the treatment of radiotherapy-induced xerostomia (LEONIDAS-2): a multicentre, randomised, double-masked sham-controlled phase 3 trial

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.

PMID:36933846 | DOI:10.1016/j.ijrobp.2023.03.047

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