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Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial

BACKGROUND: Malnutrition is common in cancer patients, particularly in those affected by gastrointestinal malignancies, and negatively affects treatment tolerance, survival, functional status, and quality of life (QoL). Nutritional support, including supplemental parenteral nutrition (SPN), has been...

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Autores principales: Caccialanza, Riccardo, Cereda, Emanuele, Klersy, Catherine, Brugnatelli, Silvia, Borioli, Valeria, Ferrari, Alessandra, Caraccia, Marilisa, Lobascio, Federica, Pagani, Anna, Delfanti, Sara, Aprile, Giuseppe, Reni, Michele, Rimassa, Lorenza, Melisi, Davide, Cascinu, Stefano, Battistini, Luca, Candiloro, Francesca, Pedrazzoli, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7036492/
https://www.ncbi.nlm.nih.gov/pubmed/32127922
http://dx.doi.org/10.1177/1758835919890281
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author Caccialanza, Riccardo
Cereda, Emanuele
Klersy, Catherine
Brugnatelli, Silvia
Borioli, Valeria
Ferrari, Alessandra
Caraccia, Marilisa
Lobascio, Federica
Pagani, Anna
Delfanti, Sara
Aprile, Giuseppe
Reni, Michele
Rimassa, Lorenza
Melisi, Davide
Cascinu, Stefano
Battistini, Luca
Candiloro, Francesca
Pedrazzoli, Paolo
author_facet Caccialanza, Riccardo
Cereda, Emanuele
Klersy, Catherine
Brugnatelli, Silvia
Borioli, Valeria
Ferrari, Alessandra
Caraccia, Marilisa
Lobascio, Federica
Pagani, Anna
Delfanti, Sara
Aprile, Giuseppe
Reni, Michele
Rimassa, Lorenza
Melisi, Davide
Cascinu, Stefano
Battistini, Luca
Candiloro, Francesca
Pedrazzoli, Paolo
author_sort Caccialanza, Riccardo
collection PubMed
description BACKGROUND: Malnutrition is common in cancer patients, particularly in those affected by gastrointestinal malignancies, and negatively affects treatment tolerance, survival, functional status, and quality of life (QoL). Nutritional support, including supplemental parenteral nutrition (SPN), has been recommended at the earliest opportunity in malnourished cancer patients. The limited available evidence on the efficacy of SPN in gastrointestinal cancer patients is positive, particularly with regards to QoL, body composition, and energy intake, but the evidence on survival is still scanty. Furthermore, studies regarding the early administration of SPN in combination with nutritional counseling from the beginning of first-line chemotherapy (CT) are lacking. We hypothesize that early systematic SPN in combination with nutritional counseling (NC), compared with NC alone, can benefit patients with previously untreated metastatic gastric cancer at nutritional risk undergoing first-line CT. METHODS: The aim of this pragmatic, multicenter, randomized (1:1), parallel-group, open-label, controlled clinical trial is to evaluate the efficacy in terms of survival, weight maintenance, body composition, QoL and feasibility of cancer therapy of early systematic SNP. This is in combination with NC, compared with NC alone, in treatment-naïve metastatic gastric cancer patients at nutritional risk undergoing first-line CT. DISCUSSION: Malnutrition in oncology remains an overlooked problem. Although the importance of SPN in gastrointestinal cancer patients has been acknowledged, no studies have yet evaluated the efficacy of early SPN in metastatic gastric patients undergoing CT. The present study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early intensive nutritional support in cancer patients undergoing CT. This study could stimulate further large randomized trials in different cancer types, potentially resulting in the improvement of supportive care quality. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov: NCT03949907.
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spelling pubmed-70364922020-03-03 Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial Caccialanza, Riccardo Cereda, Emanuele Klersy, Catherine Brugnatelli, Silvia Borioli, Valeria Ferrari, Alessandra Caraccia, Marilisa Lobascio, Federica Pagani, Anna Delfanti, Sara Aprile, Giuseppe Reni, Michele Rimassa, Lorenza Melisi, Davide Cascinu, Stefano Battistini, Luca Candiloro, Francesca Pedrazzoli, Paolo Ther Adv Med Oncol Study Protocol BACKGROUND: Malnutrition is common in cancer patients, particularly in those affected by gastrointestinal malignancies, and negatively affects treatment tolerance, survival, functional status, and quality of life (QoL). Nutritional support, including supplemental parenteral nutrition (SPN), has been recommended at the earliest opportunity in malnourished cancer patients. The limited available evidence on the efficacy of SPN in gastrointestinal cancer patients is positive, particularly with regards to QoL, body composition, and energy intake, but the evidence on survival is still scanty. Furthermore, studies regarding the early administration of SPN in combination with nutritional counseling from the beginning of first-line chemotherapy (CT) are lacking. We hypothesize that early systematic SPN in combination with nutritional counseling (NC), compared with NC alone, can benefit patients with previously untreated metastatic gastric cancer at nutritional risk undergoing first-line CT. METHODS: The aim of this pragmatic, multicenter, randomized (1:1), parallel-group, open-label, controlled clinical trial is to evaluate the efficacy in terms of survival, weight maintenance, body composition, QoL and feasibility of cancer therapy of early systematic SNP. This is in combination with NC, compared with NC alone, in treatment-naïve metastatic gastric cancer patients at nutritional risk undergoing first-line CT. DISCUSSION: Malnutrition in oncology remains an overlooked problem. Although the importance of SPN in gastrointestinal cancer patients has been acknowledged, no studies have yet evaluated the efficacy of early SPN in metastatic gastric patients undergoing CT. The present study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early intensive nutritional support in cancer patients undergoing CT. This study could stimulate further large randomized trials in different cancer types, potentially resulting in the improvement of supportive care quality. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov: NCT03949907. SAGE Publications 2020-02-22 /pmc/articles/PMC7036492/ /pubmed/32127922 http://dx.doi.org/10.1177/1758835919890281 Text en © The Author(s), 2020 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Study Protocol
Caccialanza, Riccardo
Cereda, Emanuele
Klersy, Catherine
Brugnatelli, Silvia
Borioli, Valeria
Ferrari, Alessandra
Caraccia, Marilisa
Lobascio, Federica
Pagani, Anna
Delfanti, Sara
Aprile, Giuseppe
Reni, Michele
Rimassa, Lorenza
Melisi, Davide
Cascinu, Stefano
Battistini, Luca
Candiloro, Francesca
Pedrazzoli, Paolo
Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
title Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
title_full Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
title_fullStr Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
title_full_unstemmed Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
title_short Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
title_sort early intravenous administration of nutritional support (ivans) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7036492/
https://www.ncbi.nlm.nih.gov/pubmed/32127922
http://dx.doi.org/10.1177/1758835919890281
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