title: Phase III double-blind, placebo-controlled study of gabapentin for the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, NCCTG N08C3 (Alliance).
abstract: BACKGROUND
  Despite targeted antiemetics, data support an unmet need related to the management of delayed nausea and vomiting (NV). Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy (HEC).
  
  
  METHODS
  Participants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist (RA) on the day of chemotherapy, followed by gabapentin 300 mg twice a day and dexamethasone (dex) or placebo and dex after HEC. Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle, whereas dex was titrated down on days 2-4. The primary end point was complete response (CR), defined as no emesis and no use of rescue medications on days 2-6, using an NV diary. The percentages of those in each group with a CR were compared by Fisher's exact test.
  
  
  RESULTS
  Four hundred thirty patients were enrolled in this study. Forty-seven percent of patients in the gabapentin arm and 41% in the placebo arm had a CR (P = .23). Mean number of emesis episodes was <0.5 daily, and mean nausea severity was < 2 (mild). In both arms, patient satisfaction with NV control was greater than 8 (with 10 being perfectly satisfied). There were no significant differences in unwanted side effects.
  
  
  CONCLUSIONS
  In this study, gabapentin did not significantly improve delayed NV. Patients were satisfied with the control of their nausea and vomiting irrespective of arm. The use of a 5HT3 RA and dexamethasone provided good control of nausea and vomiting for most patients.
authors.affiliation: Mayo Clinic Rochester, Rochester, Minnesota.
authors.forename: Debra L
authors.initials: DL
authors.lastname: Barton
authors.forename: Gita
authors.initials: G
authors.lastname: Thanarajasingam
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
authors.forename: Brent
authors.initials: B
authors.lastname: Diekmann
authors.forename: Jyotsna
authors.initials: J
authors.lastname: Fuloria
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Kottschade
authors.forename: Alan P
authors.initials: AP
authors.lastname: Lyss
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Jaslowski
authors.forename: Miroslaw A
authors.initials: MA
authors.lastname: Mazurczak
authors.forename: Scott C
authors.initials: SC
authors.lastname: Blair
authors.forename: Shelby
authors.initials: S
authors.lastname: Terstriep
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
mesh_terms: D000328:Adult; D000368:Aged; D000588:Amines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy*; D017060:Patient Satisfaction; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000970:Antineoplastic Agents; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
keywords: antiemetic therapy; delayed nausea; delayed vomiting; gabapentin; randomized controlled trial