Parenteral hydration in patients with advanced cancer: a multicenter, double-blind, placebo-controlled randomized trial

J Clin Oncol. 2013 Jan 1;31(1):111-8. doi: 10.1200/JCO.2012.44.6518. Epub 2012 Nov 19.


Purpose: 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.

Patients and 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).

Conclusion: Hydration at 1 L per day did not improve symptoms, quality of life, or survival compared with placebo.

Trial registration: NCT00423722.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Dehydration / therapy*
  • Double-Blind Method
  • Fatigue / prevention & control
  • Female
  • Fluid Therapy*
  • Follow-Up Studies
  • Hospice Care*
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / complications*
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / therapy
  • Neoplasms / complications*
  • Neoplasms / mortality
  • Neoplasms / therapy
  • Parenteral Nutrition*
  • Prognosis
  • Quality of Life*
  • Survival Rate
  • Symptom Assessment

Associated data