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Early 7-day supplemental parenteral nutrition improves body composition and muscle strength in hypophagic cancer patients at nutritional risk

Abstract

Purpose

The international guidelines recommend the use of supplemental parenteral nutrition (SPN) in cancer patients when they are malnourished and hypophagic and where enteral nutrition is not feasible. However, there are limited data on the short-term effects of SPN in this patient population.

Methods

The aim of this bicentric single-arm clinical trial (NCT02828150) was to evaluate the effects of early 7-day SPN on bioimpedance vectorial analysis (BIVA)–derived body composition, handgrip strength (HG), and serum prealbumin (PAB) in 131 hypophagic, hospitalized cancer patients at nutritional risk, with contraindications for enteral nutrition.

Results

One hundred eighteen patients (90.1%) completed the 7-day SPN support regimen and 102 of them (86.4%) were in advanced disease stage.

SPN induced a significant improvement of phase angle (PhA, + 0.25 [95% CI 0.11, 0.39]; p = 0.001), standardized phase angle (SPA, + 0.33 [95% CI 0.13, 0.53]; p = 0.002), HG (+ 2.1 kg -95% CI 1.30, 2.81]; p < 0.001), and PAB (+ 3.8 mg/dL [95% CI 2.1, 5.6]; p < 0.001).

In multivariable analysis, the effects on BIVA parameters were more pronounced in patients (N = 90, 76.3%) in whom estimated protein and calorie requirements were both satisfied (adjusted difference: PhA, + 0.39 [95% CI 0.04, 0.73]; p = 0.030; SPA, + 0.62 [95% CI 0.16, 1.09]; p = 0.009).

No significant changes in hydration status were detected and no severe metabolic or other complications occurred.

Conclusions

Early 7-day SPN resulted in improved body composition, HG and PAB levels in hypophagic, and hospitalized cancer patients at nutritional risk in the absence of any relevant clinical complications. Further trials, aimed at verifying the efficacy of this early nutritional intervention on mid- and long-term primary clinical endpoints in specific cancer types, are warranted.

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Authorship

RC, EC, CK, and PP participated in the study concept and design. RC, EC, PP, MN, MC, SC, VB, AT, II, AL, JS, LC, MB, and VZ participated in the clinical evaluation and management of the patients and in the data collection and interpretation. RC, EC, CK, and PP participated in writing the manuscript. CK performed the statistical analysis.

All authors approved the final version of the manuscript.

Financial support

The study was funded by the Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, and by a grant from Baxter Healthcare Corporation.

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Corresponding author

Correspondence to Riccardo Caccialanza.

Ethics declarations

The study was approved by the Institutional Ethics Committee of the Fondazione IRCCS Policlinico San Matteo (Pavia, Italy) and by the Ethics Committee of the Veneto Institute of Oncology-IRCCS (Padova, Italy). It was conducted according to the Declaration of Helsinki. Written informed consent was obtained from each patient.

Conflict of interest

RC has received research funding from Baxter Healthcare Corporation. RC and PP have served as consultants and/or on advisory panels for Baxter Healthcare Corporation. RC and PP have participated in speakers’ bureaus for Baxter Healthcare Corporation. RC and EC have participated in speakers’ bureaus for Akern s.r.l.

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Caccialanza, R., Cereda, E., Caraccia, M. et al. Early 7-day supplemental parenteral nutrition improves body composition and muscle strength in hypophagic cancer patients at nutritional risk. Support Care Cancer 27, 2497–2506 (2019). https://doi.org/10.1007/s00520-018-4527-0

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  • DOI: https://doi.org/10.1007/s00520-018-4527-0

Keywords

  • Supplemental parenteral nutrition
  • Cancer
  • Malnutrition
  • Bioelectrical impedance vectorial analysis
  • Body composition
  • Handgrip strength