A double-blind randomized trial comparing outpatient parenteral nutrition with intravenous hydration: Effect on resumption of oral intake after marrow transplantation

Background: Outpatient parenteral nutrition CPN) is often given to marrow transplant recipients after high-dose chemoradiotherapy until the resumption of adequate oral intake; however, it may adversely prolong resumption of oral calorie intake by contributing to early satiety. Methods: A double-blind, randomized study compared standard PN (final concentration 25% dextrose, 5% amino acids) with a hydration solution (5% dextrose) during the first 28 days of outpatient treatment. Patients were eligible for the study if they were greater than or equal to 2 years of age, <65 days posttransplant, had <70% oral caloric intake at hospital discharge, and required less than or equal to 10 U insulin/L PN. Solutions were provided until the patient's oral intake met greater than or equal to 85% caloric requirements for 3 consecutive days. Results: Two hundred fifty-eight marrow transplant recipients (128, PN and 130, hydration solution) were studied. Age, donor type, and diagnoses were similar in the two groups. Time to resumption of greater than or equal to 85% oral caloric intake was 6 days sooner in the hydration group than in the PN group (median 10 vs 16 days, respectively; p = .049). When adjusting for sex, age, donor type, total body irradiation, previous oral intake, acute graft-versus-host disease, and prednisone therapy, the hydration group resumed oral intake sooner than the PN group (relative risk = 1.51; 95% confidence interval [CI] 1.04 to 2.19; p = .029). The percentage of weight change from pretransplant values, adjusted for the above covariates and the number of weeks of treatment, indicated that the hydration solution group lost weight (4.63%) compared with the PN group (1.27%) after 4 weeks of therapy (P = .004). Rates of hospital readmissions, relapse of malignancy, and survival did not differ between the two treatment groups. Conclusions: We conclude that outpatient PN delays resumption of oral intake and that its replacement with hydration solution does not result in adverse patient outcome.