Purpose: The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer.
Methods: Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab.
Fourteen patients with recurrent or persistent carcinoma of the oral cavity or oropharynx were treated with Au-198 grain implants at the Santa Creu i Sant Pau Hospital from June 1987 through April 1991. Five patients presented recurrent carcinoma, four patients persistent carcinoma, and five patients a second primary. Local control was achieved with Au-198 implants in six patients (42.
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