Mercadante, V;
Hamad, A Al;
McCaul, J;
Nutting, C;
Harrington, K;
Carnell, D;
Urbano, T Guerrero;
... Fedele, S; + view all
(2023)
Salivary electrostimulation in the treatment of radiotherapy-induced xerostomia (LEONIDAS-2): a multicentre, randomised, double-masked sham-controlled phase 3 trial.
International Journal of Radiation: Oncology - Biology - Physics
10.1016/j.ijrobp.2023.03.047.
(In press).
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Abstract
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.
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