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Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial.

Rajesh V LallaSebastián SoléSergio BecerraClaudia CarvajalPiero BettoliHernán LetelierAlejandro SantiniLorena VargasAlexander CifuentesFrancisco LarsenNatalia JaraJorge OyarzúnRichard FeinnEva BustamanteBenjamín MartínezDavid RosenbergTomas Galván
Published in: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (2020)
The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.
Keyphrases
  • double blind
  • placebo controlled
  • radiation induced
  • phase iii
  • clinical trial
  • phase ii
  • open label
  • radiation therapy
  • study protocol
  • phase ii study
  • early onset
  • squamous cell carcinoma