Parenteral hydration did not improve dehydration or quality of life in advanced cancer

Reitschuler-Cross EB, Arnold B. — Tue, 19 Mar 2013 00:00:00 GMT

Question

In patients with advanced cancer who were receiving home hospice care, does parenteral hydration improve symptoms of dehydration, quality of life, or survival?

Methods

Design

Randomized placebo-controlled trial.

Allocation

Concealed.*

Blinding

Blinded* (patients and outcome assessors).

Follow-up period

4 and 7 days.

Setting

5 hospices in Houston, Texas, USA.

Patients

129 patients ≥ 18 years of age (median age 67 y, 53% men) who had advanced cancer and were admitted to home hospice care; had reduced oral intake of fluids; mild or moderate dehydration; score ≥ 1 (scale of 0 to 10, 10 = worst possible symptom) for fatigue and ≥ 2 of 3 symptoms of hallucinations, sedation, or myoclonus; life expectancy ≥ 1 week; Memorial Delirium Assessment Scale score < 13 (range 0 to 30, delirium present if ≥ 7); and an available primary caregiver. Exclusion criteria were severe dehydration or history or clinical evidence of renal failure, congestive heart failure, or bleeding disorders.

Intervention

Hydration (normal saline, 1000 mL) (n = 63) or placebo (normal saline, 100 mL) (n = 66), infused subcutaneously over 4 h/d until the patient was unresponsive, developed progressive coma, or died.

Outcomes

Primary outcome was change in the sum of scores for dehydration symptoms (fatigue, myoclonus, sedation, and hallucinations) at day 4, using the Edmonton Symptom Assessment Scale (range 0 to 10 per symptom, 10 = worst possible symptom, maximum 40). Secondary outcomes included quality of life (Functional Assessment of Chronic Illness Therapy–Fatigue subscale [FACIT-F]), and survival. 150 patients were required to detect a difference of 0.50 standard deviation units (i.e., 4.2 points on the 40-point primary outcome scale) with a power of 80% (α = 0.05). The study was stopped early due to a funding shortage.

Patient follow-up

79% for primary outcome and 86% for survival (intention-to-treat analysis).

Main results

Hydration did not differ from placebo for improvement in symptoms of dehydration or quality of life (Table). Median survival did not differ between groups (21 vs 15 d, log rank test P = 0.83).

Conclusion

In patients with advanced cancer who were receiving hospice care at home, parenteral hydration did not improve dehydration symptoms, quality of life, or survival.Hydration (normal saline, 1000 mL) vs placebo (normal saline, 100 mL) in patients with advanced cancer†OutcomesDayMean change from baselineP valueHydrationPlaceboDehydration symptoms‡Day 4−3.3−2.80.77FACIT-F§Day 79.11.40.23†FACIT-F = Functional Assessment of Chronic Illness Therapy–Fatigue.‡Change in sum of scores for fatigue, myoclonus, sedation, and hallucinations using the Edmonton Symptom Assessment Scale (range 0 to 10 per symptom, 10 = worst possible symptom).§Quality of life measured baseline to day 7 using FACIT–F subscale (13 items rated 0 to 4, higher values = increased intensity of fatigue).

Annals of Internal Medicine: End-of-Life Care Topic Collection

Parenteral hydration did not improve dehydration or quality of life in advanced cancer