title: Oral Lapacho-Based Medication: An Easy, Safe, and Feasible Support to Prevent and/or Reduce Oral Mucositis During Radiotherapy for Head and Neck Cancer.
abstract: The aim of our Phase II study is to demonstrate the benefits, safety, and tolerance of Orasol Plus, an easy and feasible Lapacho-based medication. Orasol Plus is a nutritional, swallowable solution, useful to support the defenses of the oropharyngeal mucosa. Between January and June 2014, 40 consecutive adult patients affected by head and neck cancer were enrolled. Orasol Plus was administered 3 times a day from the first day till the end of radiotherapy. Primary endpoint was to evaluate tolerance and safety of Orasol Plus; secondary endpoint was to evaluate the effect of Orasol Plus on the incidence of treatment discontinuation. Nearly all patients used Orasol Plus easily till the end of radiotherapy without interruptions. Only 11 (27.5%) patients developed oral mucositis (OM) Grade 2 and only 4 (10%) patients OM Grade 3, no patient developed OM Grade 4. No patient discontinued radiotherapy because of OM. Orasol Plus was well tolerated and the compliance of patients was optimal, mainly due to the fact that it can be swallowed. Data from our study are encouraging and they need to be confirmed by a Phase III study.
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Giacomelli
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Scartoni
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Meacci
authors.initials: M
authors.lastname: Fiammetta
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Muhammed
authors.initials: M
authors.lastname: Baki
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Zei
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Muntoni
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Cappelli
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Greto
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Scoccianti
authors.affiliation: a Department of Radiation Oncology , University of Florence , Florence , Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Livi
mesh_terms: D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects; D019587:Dietary Supplements; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D013280:Stomatitis / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D029663:Tabebuia
chemical_list: D028321:Plant Preparations