Riccardo Caccialanza1, Emanuele Cereda2, Marilisa Caraccia2, Catherine Klersy3, Mariateresa Nardi4, Silvia Cappello2, Valeria Borioli2, Annalisa Turri2, Ilaria Imarisio5, Angioletta Lasagna5, Jessica Saddi5, Luca Arcaini6, Marco Benazzo7, Silvia Stragliotto8, Vittorina Zagonel8, Paolo Pedrazzoli9. 1. Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia, Italy. r.caccialanza@smatteo.pv.it. 2. Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, 27100, Pavia, Italy. 3. Biometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 4. Clinical Nutrition Service, Veneto Institute of Oncology-IRCCS, Padua, Italy. 5. Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 6. Division of Hematology, Fondazione IRCCS Policlinico San Matteo and Department of Molecular Medicine, University of Pavia, Pavia, Italy. 7. Department of Otolaryngology Head Neck Surgery and Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy. 8. Medical Oncology 1, Veneto Institute of Oncology-IRCCS, Padua, Italy. 9. Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo and Department of Internal Medicine, University of Pavia, Pavia, Italy.
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.
PURPOSE: The international guidelines recommend the use of supplemental parenteral nutrition (SPN) in cancerpatients 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 cancerpatients 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 cancerpatients 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.
Authors: Riccardo Caccialanza; Alessandro Laviano; Cristina Bosetti; Mariateresa Nardi; Valentina Casalone; Lucilla Titta; Roberto Mele; Giovanni De Pergola; Francesco De Lorenzo; Paolo Pedrazzoli Journal: Support Care Cancer Date: 2022-07-06 Impact factor: 3.603
Authors: Paolo Cotogni; Paolo Pedrazzoli; Elisabeth De Waele; Giuseppe Aprile; Gabriella Farina; Silvia Stragliotto; Francesco De Lorenzo; Riccardo Caccialanza Journal: J Cancer Date: 2019-07-10 Impact factor: 4.207
Authors: Neil Webb; Julie Fricke; Elizabeth Hancock; David Trueman; Srobana Ghosh; Julie Winstone; Alec Miners; Julian Shepelev; Juan W Valle Journal: ESMO Open Date: 2020-06