title: Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a North Central Cancer Treatment Group study.
abstract: OBJECTIVE
  To determine whether dronabinol administered alone or with megestrol acetate was more, less, or equal in efficacy to single-agent megestrol acetate for palliating cancer-associated anorexia.
  
  
  METHODS
  Four hundred sixty-nine assessable advanced cancer patients were randomized to (1) oral megestrol acetate 800 mg/d liquid suspension plus placebo, (2) oral dronabinol 2.5 mg twice a day plus placebo, or (3) both agents. Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight.
  
  
  RESULTS
  Groups were comparable at baseline in age, sex, tumor type, weight loss, and performance status. A greater percentage of megestrol acetate-treated patients reported appetite improvement and weight gain compared with dronabinol-treated patients: 75% versus 49% (P =.0001) for appetite and 11% versus 3% (P =.02) for > or = 10% baseline weight gain. Combination treatment resulted in no significant differences in appetite or weight compared with megestrol acetate alone. The Functional Assessment of Anorexia/Cachexia Therapy questionnaire, which emphasizes anorexia-related questions, demonstrated an improvement in quality of life (QOL) among megestrol acetate-treated and combination-treated patients. The single-item Uniscale, a global QOL instrument, found comparable scores. Toxicity was also comparable, with the exception of an increased incidence of impotence among men who received megestrol acetate.
  
  
  CONCLUSIONS
  In the doses and schedules we studied, megestrol acetate provided superior anorexia palliation among advanced cancer patients compared with dronabinol alone. Combination therapy did not appear to confer additional benefit.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. jatoi.aminah@mayo.edu
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.forename: Harold E
authors.initials: HE
authors.lastname: Windschitl
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: Jeff A
authors.initials: JA
authors.lastname: Sloan
authors.forename: Shaker R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: James A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: Sarode
authors.initials: S
authors.lastname: Pundaleeka
authors.forename: Carl G
authors.initials: CG
authors.lastname: Kardinal
authors.forename: Tom R
authors.initials: TR
authors.lastname: Fitch
authors.forename: James E
authors.initials: JE
authors.lastname: Krook
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Novotny
authors.forename: Brad
authors.initials: B
authors.lastname: Christensen
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000855:Anorexia / Q000188:drug therapy* / Q000209:etiology*; D001066:Appetite / Q000187:drug effects*; D004311:Double-Blind Method; D013759:Dronabinol / Q000009:adverse effects / Q000494:pharmacology*; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D019290:Megestrol Acetate / Q000009:adverse effects / Q000494:pharmacology*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000494:pharmacology*; D011788:Quality of Life; D015430:Weight Gain
chemical_list: D011619:Psychotropic Drugs; D013759:Dronabinol; D019290:Megestrol Acetate