A randomized phase II study to assess the effectiveness of fluid therapy or intensive nutritional support on survival in patients with advanced cancer who cannot be nourished via enteral route

Abstract

Background: Experts advise against parenteral nutrition (PN) for patients with advanced cancer at the end of life. But because many patients and families fear starvation, many physicians administer PN to patients with terminal cancer in Korea.

Objective: We designed this study to investigate the effect of PN on survival in patients with terminal cancer at the end of life.

Design: We planned a randomized phase II study enrolling 116 patients randomized to receive either fluid or PN.

Setting/subjects: Eligible patients are who could not tolerate enteral feeding and had short life expectancies (<3 months) due to progressive cancer. Patients with functioning bowels were excluded.

Measurements: The primary end point was overall survival and the secondary end point was total administered calories.

Results: We prospectively enrolled 31 consecutive patients and 16 patients were assigned to the PN group. The study ended early because many patients and families were extremely concerned about starvation. The baseline characteristics, including nutritional parameters, were not significantly different between the two groups. The mean administered calories was 374.7 (± 71.7) kcal/d for the fluid group and 1286.8 (± 108.3) kcal/d for the PN group (p<0.001). Median survival was 8 days (95% confidence interval [CI], 5.7-10.3 days) in the fluid group and 13 days (95% CI: 3.1-22.9 days) in the PN group, and this difference was not statistically significant (p = 0.982 by Log-rank test).

Conclusions: This study did not conclusively determine the role of PN for patients with advanced cancer, however, PN support failed to significantly prolong survival in these patients compared to similar patients receiving only fluid.