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Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.

A LozanoJ MarruecosJ RubióN FarréJ Gómez-MillánR MoreraI PlanasM LanzuelaM G Vázquez-MasedoL CascallarJ GiraltG EscamesVicente ValentíP GrimaR BosserC TarragóR Mesía
Published in: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico (2021)
Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial.
Keyphrases
  • phase iii
  • placebo controlled
  • clinical trial
  • double blind
  • open label
  • radiation therapy
  • phase ii
  • study protocol
  • risk factors
  • squamous cell carcinoma
  • locally advanced