title: Dexamethasone for the prophylaxis of radiation-induced emesis: a National Cancer Institute of Canada Clinical Trials Group phase III study.
abstract: OBJECTIVE
  To investigate the efficacy of dexamethasone as a prophylactic antiemetic for patients receiving fractionated radiotherapy to the upper abdomen in a randomized controlled trial.
  
  
  METHODS
  One hundred fifty-four patients planned to receive fractionated radiotherapy to fields involving the upper abdomen (minimum total dose, 20 Gy; minimum number of fractions, five) were randomized to receive prophylactic dexamethasone (2 mg orally three times a day [tid], starting in the morning of first treatment and continuing until after their fifth treatment) or placebo. The primary end point of the study was the proportion of patients free from emesis during the study period. Secondary end points included a quality-of-life assessment using the core questionnaire of the European Organization for Research and Treatment of Cancer and side effects of dexamethasone therapy in this population of patients.
  
  
  RESULTS
  Fifty-four (70%) out of 75 patients receiving dexamethasone had complete protection versus 37 (49%) out of 75 patients on placebo (P = .025). Most emetic episodes occurred during the initial phase of treatment. Although there was no difference in global quality of life between the two sets of patients, patients receiving dexamethasone had less nausea and vomiting and less loss of appetite but more insomnia.
  
  
  CONCLUSIONS
  Dexamethasone 2 mg tid seems to be an effective prophylactic antiemetic in this situation. Side effects were acceptable, but there seemed to be no overall effect on global quality of life.
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada. pkirkbride@WPH.TRENT.NHS.UK
authors.forename: P
authors.initials: P
authors.lastname: Kirkbride
authors.forename: A
authors.initials: A
authors.lastname: Bezjak
authors.forename: J
authors.initials: J
authors.lastname: Pater
authors.forename: B
authors.initials: B
authors.lastname: Zee
authors.forename: M J
authors.initials: MJ
authors.lastname: Palmer
authors.forename: R
authors.initials: R
authors.lastname: Wong
authors.forename: P
authors.initials: P
authors.lastname: Cross
authors.forename: S
authors.initials: S
authors.lastname: Gulavita
authors.forename: P
authors.initials: P
authors.lastname: Blood
authors.forename: A
authors.initials: A
authors.lastname: Sun
authors.forename: G
authors.initials: G
authors.lastname: Dundas
authors.forename: P K
authors.initials: PK
authors.lastname: Ganguly
authors.forename: J
authors.initials: J
authors.lastname: Lim
authors.forename: A D
authors.initials: AD
authors.lastname: Chowdhury
authors.forename: S E
authors.initials: SE
authors.lastname: Kumar
authors.forename: A R
authors.initials: AR
authors.lastname: Dar
mesh_terms: D000005:Abdomen / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000532:radiotherapy; D011788:Quality of Life; D011878:Radiotherapy / Q000009:adverse effects*; D016896:Treatment Outcome; D014839:Vomiting / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D003907:Dexamethasone