A randomized, placebo-controlled trial of parenteral hydration in terminally ill cancer patients

Abstract

8004 Background: Most cancer patients develop decreased oral intake and dehydration before death. Parenteral hydration is provided to almost no patients in hospices and almost all patients in acute care facilities. Methods: 51 Patients with clinical evidence of mild to moderate dehydration and oral intake of less than 1000 ml per day were randomized to receive parenteral hydration with 1000 ml normal saline (SC or IV) versus placebo (100 ml normal saline SC or IV) over 4 hours on days 1 and 2. Patients were evaluated for target symptoms (hallucinations, myoclonus, fatigue and sedation), and global well being at baseline and on day 2 of the study using 0 to 10 numerical scales. Overall benefit of the treatment was assessed by the patient and the investigator using 1 to 7 scales. Results: 49 patients were evaluable (96%): 27 patients randomized to parenteral hydration had improvement in 53/73 (73%) evaluable target symptoms versus 33/67 (49%) in 22 patients who received placebo (p=0.005). 15/18 (83%) and 15/18 (83%) patients had improved myoclonus and sedation after hydration versus 8/17 (47%) and 5/15 (33%) after placebo (p=0.03 and p=0.005, respectively). There were no significant differences of improvement in hallucinations and fatigue. Patients assessed hydration as effective in 17/27 (63%) cases and placebo effective in 9/22 (41%) cases (p=0.78). Investigators found hydration was effective in 20/27 (74%) cases and placebo in 12/22 (54%) cases (p=0.15). The mean of pain and swelling at the injection site in subcutaneous hydration (n=20) and subcutaneous placebo (n=17) were 2.1 (+/-2.95) versus 1.75 (+/-2.55) (p=0.1), and 0.82 (+/-1.13) versus 1.41 (=/-1.66) (p=0.64), respectively. Conclusions: Parenteral hydration improved symptoms in terminally ill cancer patients with decreased fluid intake. Hydration was well tolerated and placebo effect were observed. Studies with longer follow-up are required. No significant financial relationships to disclose.