Mucoadhesive clonidine (Clonidine Lauriad) in the prevention of severe radiomucositis in head and neck cancer patients: A phase II randomized trial.

6058 Background: Oral mucositis (OM) is the most frequent and severe complication of chemoradiotherapy (CRT) in head and neck cancer patients. There is currently no effective mechanistically-targeted intervention for CRT-induced OM. NF-κB plays a central role in the signaling cascades and pathways responsible for OM. Clonidine reduces NF-κB activation and the subsequent expression of pro-inflammatory cytokines. In preclinical studies, topical clonidine reduced the incidence and duration of severe OM (SOM). The safety and efficacy of 2 doses of clonidine MBT were evaluated in patients with head and neck cancer receiving postoperative CRT. Methods: This phase 2, multicenter, double-blind, randomized, placebo-controlled, 3-arm study compared clonidine MBT 50µg, 100µg, and placebo. Clonidine MBT and matching placebo were applied to the gum once daily 1-3 days prior to RT until the end of CRT. The primary endpoint was the cumulative radiation dose at the onset of SOM (WHO grade 3 or 4) analyzed by the Kaplan-M...