title: Parenteral hydration in patients with advanced cancer: a multicenter, double-blind, placebo-controlled randomized trial.
abstract: OBJECTIVE
  The vast majority of patients with cancer at the end of life receive parenteral hydration in hospitals and no hydration in hospice, with limited evidence supporting either practice. In this randomized controlled trial, we determined the effect of hydration on symptoms associated with dehydration, quality of life, and survival in patients with advanced cancer.
  
  
  METHODS
  We randomly assigned 129 patients with cancer from six hospices to receive parenteral hydration (normal saline 1 L per day) or placebo (normal saline 100 mL per day) daily over 4 hours. The primary outcome was change in the sum of four dehydration symptoms (fatigue, myoclonus, sedation and hallucinations, 0 = best and 40 = worst possible) between day 4 and baseline. Secondary outcomes included Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS), Nursing Delirium Screening Scale (NuDESC), Unified Myoclonus Rating Scale (UMRS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Dehydration Assessment Scale, creatinine, urea, and overall survival. Intention-to-treat analysis was conducted to examine the change by day 4 ± 2 and day 7 ± 2 between groups.
  
  
  RESULTS
  The hydration (n = 63) and placebo (n = 66) groups had similar baseline characteristics. We found no significant differences between the two groups for change in the sum of four dehydration symptoms (-3.3 v -2.8, P = .77), ESAS (all nonsignificant), MDAS (1 v 3.5, P = .084), NuDESC (0 v 0, P = .13), and UMRS (0 v 0, P = .54) by day 4. Results for day 7, including FACIT-F, were similar. Overall survival did not differ between the two groups (median, 21 v 15 days, P = .83).
  
  
  CONCLUSIONS
  Hydration at 1 L per day did not improve symptoms, quality of life, or survival compared with placebo.
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. ebruera@mdanderson.org
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
authors.forename: David
authors.initials: D
authors.lastname: Hui
authors.forename: Shalini
authors.initials: S
authors.lastname: Dalal
authors.forename: Isabel
authors.initials: I
authors.lastname: Torres-Vigil
authors.forename: Joseph
authors.initials: J
authors.lastname: Trumble
authors.forename: Joseph
authors.initials: J
authors.lastname: Roosth
authors.forename: Susan
authors.initials: S
authors.lastname: Krauter
authors.forename: Carol
authors.initials: C
authors.lastname: Strickland
authors.forename: Kenneth
authors.initials: K
authors.lastname: Unger
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
authors.forename: Julio
authors.initials: J
authors.lastname: Allo
authors.forename: Susan
authors.initials: S
authors.lastname: Frisbee-Hume
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tarleton
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003681:Dehydration / Q000628:therapy*; D004311:Double-Blind Method; D005221:Fatigue / Q000517:prevention & control; D005260:Female; D005440:Fluid Therapy; D005500:Follow-Up Studies; D017051:Hospice Care; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000150:complications* / Q000401:mortality / Q000628:therapy; D009369:Neoplasms / Q000150:complications* / Q000401:mortality / Q000628:therapy; D010288:Parenteral Nutrition; D011379:Prognosis; D011788:Quality of Life; D015996:Survival Rate; D063189:Symptom Assessment