title: Effectiveness of tapentadol prolonged release for the management of painful mucositis in head and neck cancers during intensity modulated radiation therapy.
abstract: To evaluate the effectiveness and tolerability profile of tapentadol prolonged release (PR) in a cohort of head and neck cancer (HNC) patients affected by background pain due to painful mucositis during intensity modulated radiation therapy with or without cisplatin with definitive and adjuvant intent.
  
  
  
  Tapentadol PR was administered at the moment of pain onset in opioid-naive patients at the dosage of 50 mg BID. The dosage was increased 50 mg twice a day until the optimal dose of no more than 500 mg/day of tapentadol PR. Primary endpoint of the analysis was the evaluation of improved assessment using the numerical rating scale (NRS). Secondary endpoints were as follows: (1) assessment of the treatment received using the patients' global impression of change (PGIC) scale; (2) weight increase/stability; (3) sleep quality; and (4) tolerability. The period of observation was 90 days from the start of antineoplastic treatment.
  
  
  
  Between September 2014 and May 2015, 30 HNC patients were observed. The average age was 64.9 years (range, 36-80). Twenty-two days after the start of antineoplastic treatment, tapentadol PR was administered to 25 % of patients. This percentage was increased to 50 % after 39 days and to 75 % after 43 days. Considering the efficacy of tapentadol PR on daily pain, there was a reduction of 30 % (95 % C.I. 69.3 ÷ 96.2 %) in the pain score in 26 patients (86.7 %), and a reduction of 50 % (95 % C.I. 57.7 ÷ 90.1 %) in 23 patients (76.7 %).
  
  
  
  The use of tapentadol PR is feasible and well tolerated in HNC patients affected by background pain due to painful mucositis during intensity modulated radiotherapy with or without cisplatin. Further studies are needed to enhance current findings.
authors.affiliation: Radiation Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy. rosariomazzola@hotmail.it.
authors.forename: Mazzola
authors.initials: M
authors.lastname: Rosario
authors.affiliation: Radiation Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Ricchetti
authors.initials: R
authors.lastname: Francesco
authors.affiliation: Radiation Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Fersino
authors.initials: F
authors.lastname: Sergio
authors.affiliation: Radiation Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Giaj Levra
authors.initials: GL
authors.lastname: Niccolò
authors.affiliation: Radiation Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Fiorentino
authors.initials: F
authors.lastname: Alba
authors.affiliation: Medical Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Nicodemo
authors.initials: N
authors.lastname: Maurizio
authors.affiliation: Head Neck Surgery, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Albanese
authors.initials: A
authors.lastname: Sergio
authors.affiliation: Medical Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Gori
authors.initials: G
authors.lastname: Stefania
authors.affiliation: Radiation Oncology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy.
authors.forename: Alongi
authors.initials: A
authors.lastname: Filippo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059350:Chronic Pain / Q000188:drug therapy*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced / Q000188:drug therapy*; D010636:Phenols / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects* / Q000379:methods; D012189:Retrospective Studies; D000077432:Tapentadol
chemical_list: D010636:Phenols; D000077432:Tapentadol
keywords: Head neck cancer; Mucositis; Pain; Radiotherapy; Tapentadol