title: Oral Platelet Gel Supernatant Plus Supportive Medical Treatment Versus Supportive Medical Treatment in the Management of Radiation-induced Oral Mucositis: A Matched Explorative Active Control Trial by Propensity Analysis.
abstract: OBJECTIVE
  In this active control trial, the rate of radio-induced WHO grade 3/4 oral mucositis and the change in quality of life, assessed by OMWQ-HN, were measured in subjects with head and neck cancer treated by platelet gel supernatant (PGS) and supportive medical treatment versus subjects treated by supportive medical treatment alone.
  
  
  METHODS
  Eighty patients with nonmetastatic head and neck cancer underwent curative or adjuvant radiotherapy. All patients underwent supportive medical treatment and/or PGS at the beginning and during radiotherapy. Sixteen patients received PGS in association with supportive medical treatment. To obtain 2 groups virtually randomized for important clinical characteristics subjects were matched, by propensity analysis, with a group of subjects (64 patients) treated with supportive medical treatment alone.
  
  
  RESULTS
  Subjects treated with standard supportive treatment experienced significant higher WHO grade 3/4 toxicity (55%; 35/64) than subjects treated by PGS (13%; 3/16). The reduced toxicity found in PGS group paralleled with the evidence that they developed later symptoms with respect to controls. The Cox proportional hazard model indicated that patients treated with standard supportive medical treatment experienced 2.7-fold increase (hazard ratio=2.7; 95% confidence interval, 1.3-5.7) in the occurrence of WHO grade 3/4 toxicity. PGS group significantly experienced higher quality of life than control groups as measured by OMWQ-HN. A significant decrease in the opioid analgesics usage was found in the PGS group.
  
  
  CONCLUSIONS
  These preliminary data should be interpreted with caution and could serve as a framework around which to design future trials.
authors.affiliation: *Division of Radiotherapy, San Salvatore Hospital ‡Department of Health Sciences, Division of Transfusion Medicine †Department of Biotechnological and Applied Clinical Sciences, Division of Radiotherapy and Radiobiology ¶Department of Biotechnological and Applied Clinical Sciences, Division of Radiology, San Salvatore Hospital, University of L'Aquila §Servise of Medical Physics; San Salvatore Hospital, L'Aquila ∥Department of Radiological Sciences-Oncology and Pathological Anatomy, University of Rome "La Sapienza", Rome, Italy.
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Bonfili
authors.forename: Giovanni L
authors.initials: GL
authors.lastname: Gravina
authors.forename: Francesco
authors.initials: F
authors.lastname: Marampon
authors.forename: Anna
authors.initials: A
authors.lastname: Rughetti
authors.forename: Mario
authors.initials: M
authors.lastname: Di Staso
authors.forename: Luigi
authors.initials: L
authors.lastname: Dell'Orso
authors.forename: Francesca
authors.initials: F
authors.lastname: Vittorini
authors.forename: Roberto
authors.initials: R
authors.lastname: Moro
authors.forename: Maria E
authors.initials: ME
authors.lastname: La Verghetta
authors.forename: Silvia
authors.initials: S
authors.lastname: Parente
authors.forename: Marilisa
authors.initials: M
authors.lastname: Reale
authors.forename: Valeria
authors.initials: V
authors.lastname: Ruggieri
authors.forename: Pietro
authors.initials: P
authors.lastname: Franzese
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Tombolini
authors.forename: Carlo
authors.initials: C
authors.lastname: Masciocchi
authors.forename: Ernesto
authors.initials: E
authors.lastname: Di Cesare
mesh_terms: D000284:Administration, Oral; D001792:Blood Platelets; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000627:therapeutic use; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011832:Radiation Injuries / Q000628:therapy*; D011878:Radiotherapy / Q000009:adverse effects; D013280:Stomatitis / Q000209:etiology* / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D005782:Gels