Radicales libres y mucositis: Ensayo clínico con Mucogel.
Mucomel is a high-dose melatonin gel for oromucosal use intended for prevention and treatment of Oral Mucositis secondary to chemoradiation in Head and Neck (H&N) cancer patients. Severe Oral Mucositis (SOM) is one of the most significant adverse events in H&N cancer patients undergoing concurrent chemo/bio-radiotherapy. A Phase Ib/II, multicenter, prospective, randomised, double-blind and placebo-controlled clinical study was conducted in 84 patients with H&N cancer undergoing concurrent chemo or bioradiation. Mucomel reduced significantly the incidence and duration of Severe Oral Mucositis (SOM) and the duration of Ulcerative Oral Mucositis (UOM) as well, in those patients treated with chemoradiotherapy with cisplatin (100 mg/m2 each three weeks). Safety of melatonin oral gel was demonstrated with no relevant differences for AEs between groups or for overall response rate after 2 months of IMRT completion. In addition, in the group of melatonin the percentage of patients with the need of nutritional support therapy, particularly those patients requiring nasogastric/parenteral feeding, was also reduced compared to the placebo group, and the requiring of major opiods, and nonpharmacological treatments were also reduced in that group of patients.