title: Double-blinded, placebo-controlled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucositis following chemoradiotherapy in patients with head-and-neck cancer.
abstract: OBJECTIVE
  We performed this double-blinded, placebo-controlled study to determine the safety and efficacy of L-alanyl-L-glutamine in the prevention of mucositis in patients with head-and-neck cancer.
  
  
  METHODS
  Thirty-two patients with head-and-neck cancer were treated with chemoradiotherapy (CRT) (radiotherapy daily up to 70 Gy plus cisplatin/5-fluoruracil once a week) and were asked to participate. Twenty-nine patients received the CRT schedule and were double-blindly assigned to receive either intravenous L-alanyl-L-glutamine 0.4 g/kg weight/day or an equal volume of saline (placebo) during chemotherapy days.
  
  
  RESULTS
  Fourteen patients received L-alanyl-L-glutamine and 15 received placebo. Mucositis was assessed by the Objective Mucositis Score (OMS) and the World Health Organization (WHO) grading system. There was a significant difference in incidence of mucositis developed in patients receiving placebo compared with those who received L-alanyl-L-glutamine (p = 0.035). The number of patients with severe objective mucositis (OMS >1.49) was higher in the placebo group compared with the L-alanyl-L-glutamine group (67% vs. 14%, p = 0.007). L-alanyl-L-glutamine patients experienced less pain (three highest Numeric Rating Scale scores of 1.3/10 vs. 6.3/10 respectively, p = 0.008) and need for feeding tubes (14% vs. 60% respectively, p = 0.020) compared with placebo patients. No adverse effects related to the drug or the infusions were noted in either group.
  
  
  CONCLUSIONS
  For patients with head-and-neck cancer receiving CRT, intravenous L-alanyl-L-glutamine may be an effective preventive measure to decrease the severity of mucositis.
authors.affiliation: Translational Research Unit, Instituto de Oncologia Angel H. Roffo, Universidad de Buenos Aires, Buenos Aires, Argentina. lcerchietti@gmail.com
authors.forename: Leandro C A
authors.initials: LC
authors.lastname: Cerchietti
authors.forename: Alfredo H
authors.initials: AH
authors.lastname: Navigante
authors.forename: Maribel A
authors.initials: MA
authors.lastname: Lutteral
authors.forename: Monica A
authors.initials: MA
authors.lastname: Castro
authors.forename: Ricardo
authors.initials: R
authors.lastname: Kirchuk
authors.forename: Marcelo
authors.initials: M
authors.lastname: Bonomi
authors.forename: Maria Esther
authors.initials: ME
authors.lastname: Cabalar
authors.forename: Berta
authors.initials: B
authors.lastname: Roth
authors.forename: Graciela
authors.initials: G
authors.lastname: Negretti
authors.forename: Beatriz
authors.initials: B
authors.lastname: Sheinker
authors.forename: Patricia
authors.initials: P
authors.lastname: Uchima
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D002945:Cisplatin / Q000009:adverse effects; D004151:Dipeptides / Q000008:administration & dosage*; D004311:Double-Blind Method; D005472:Fluorouracil / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000528:radiation effects; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control*
chemical_list: D004151:Dipeptides; D002945:Cisplatin; D005472:Fluorouracil; C054122:alanylglutamine