Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO)
Background Malnutrition is a frequent problem in oncology and is associated with reduced response to cancer treatments, increased drug-related toxicity, higher rates of clinical complications, reduced quality of life (QoL) and worse prognosis. Guidelines on clinical nutrition in oncology emphasise t...
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2023-08-01
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| author | Paolo Pedrazzoli Sandro Pignata Patrizia Serra Francesco De Lorenzo Elisabetta Iannelli Toni Ibrahim Cristina Bosetti Carmine Pinto Valentina Da Prat Riccardo Caccialanza Vittorina Zagonel Filippo Montemurro Renato Cannizzaro Cristina Fortes Emanuele Cereda Alessandra Ferrari Stefania Gori Marco Tonello Francesco Serra Amanda Casirati Sara Masi Silvia Crotti Lorenzo Perrone Claudia Santucci Valentina Casalone Rosalisa Cici Giovanni De Pergola Teresa Di Lauro Iannelli Elisabetta Alessandra Longhi Cristina Mele Maria Roberto Mele Teresa Nardi Maria Debora Pezzuolo Carmelo Pozzo Lupe Sanchez Mete Guseppe Sukkar Samir |
| author_facet | Paolo Pedrazzoli Sandro Pignata Patrizia Serra Francesco De Lorenzo Elisabetta Iannelli Toni Ibrahim Cristina Bosetti Carmine Pinto Valentina Da Prat Riccardo Caccialanza Vittorina Zagonel Filippo Montemurro Renato Cannizzaro Cristina Fortes Emanuele Cereda Alessandra Ferrari Stefania Gori Marco Tonello Francesco Serra Amanda Casirati Sara Masi Silvia Crotti Lorenzo Perrone Claudia Santucci Valentina Casalone Rosalisa Cici Giovanni De Pergola Teresa Di Lauro Iannelli Elisabetta Alessandra Longhi Cristina Mele Maria Roberto Mele Teresa Nardi Maria Debora Pezzuolo Carmelo Pozzo Lupe Sanchez Mete Guseppe Sukkar Samir |
| collection | DOAJ |
| description | Background Malnutrition is a frequent problem in oncology and is associated with reduced response to cancer treatments, increased drug-related toxicity, higher rates of clinical complications, reduced quality of life (QoL) and worse prognosis. Guidelines on clinical nutrition in oncology emphasise the usefulness of early assessment of nutritional status for a prompt identification of malnutrition and the implementation of effective interventions, but no real-world clinical data are available on the adequate management of nutritional support in patients with cancer in Italy.Methods and analysis This is an observational, longitudinal, multicentre registry of patients with a new diagnosis of cancer or metastatic disease, candidates for active treatment. They will be identified in at least 15 Italian oncological centres, members of the Alliance Against Cancer Working Group ‘Survivorship Care and Nutritional Support’. At least 1500 patients with cancer are expected to be enrolled each year. Detailed clinical and nutritional data will be collected by oncologists and clinical nutritionists during the visits foreseen in the clinical practice, through an ad hoc developed digital platform (e-Nutracare). The effects of malnutrition and nutritional support—at diagnosis and during follow-up—on overall survival and progression-free survival, as well as on patients’ symptoms and QoL, will be investigated.Ethics and dissemination The study protocol was approved by the Ethics Committee of the Fondazione IRCCS Policlinico San Matteo, Pavia, Italy and from the Ethics Committees of all other participating centres. An informed consent will be obtained from each patient enrolled in the study. Study findings will be disseminated through peer-reviewed journals, conferences and patients with cancer or professional associations. The registry will allow a better monitoring of the nutritional status of patients with cancer, promoting adequate and sustainable nutritional support, with the ultimate goal of improving the care and prognosis of these patients. |
| format | Article |
| id | doaj-art-d02cf93987f641e18c0f9ba3f1804022 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-d02cf93987f641e18c0f9ba3f18040222024-11-15T02:15:08ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2023-071858Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) 0Paolo Pedrazzoli1Sandro Pignata2Patrizia Serra3Francesco De Lorenzo4Elisabetta Iannelli5Toni Ibrahim6Cristina Bosetti7Carmine PintoValentina Da Prat8Riccardo Caccialanza9Vittorina Zagonel10Filippo Montemurro11Renato Cannizzaro12Cristina Fortes13Emanuele Cereda14Alessandra Ferrari15Stefania Gori16Marco TonelloFrancesco Serra17Amanda Casirati18Sara Masi19Silvia Crotti20Lorenzo Perrone21Claudia Santucci22Valentina CasaloneRosalisa CiciGiovanni De PergolaTeresa Di LauroIannelli ElisabettaAlessandra LonghiCristina Mele MariaRoberto MeleTeresa Nardi MariaDebora PezzuoloCarmelo PozzoLupe Sanchez MeteGuseppe Sukkar Samir1Department of Neuroinflammation, University College LondonMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyIstituto Nazionale Tumori di Napoli IRCCS Fondazione G Pascale, Napoli, Italy1 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, ItalyAssociazione Italiana Malati di Cancro (AIMAC), Roma, ItalyItalian Federation of Volunteer-based Cancer Organizations, Rome, ItalyOsteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, Meldola, ItalyDepartment of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy4 General Medicine and Advanced Care Unit, San Raffaele Hospital, Milan, ItalyClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyIstituto Oncologico Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Department of Oncology 1, veneto Institute of Oncology IOV—IRCCS, Padua, ItalyDepartment of Oncology and Hematology, Candiolo Cancer Institute, Candiolo, Italy6Department of Oncological Gastroenterology, National Cancer Institute, IRCCS, Centro di Riferimento Oncologico, Aviano, ItalyIDI-IRCCS, Rome, ItalyClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyMedical Oncology Unit, Ospedale Sacro Cuore—Don Calabria—Negrar (VR), negrar, ItalyMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyClinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyMedical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyDepartment of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, ItalyBackground Malnutrition is a frequent problem in oncology and is associated with reduced response to cancer treatments, increased drug-related toxicity, higher rates of clinical complications, reduced quality of life (QoL) and worse prognosis. Guidelines on clinical nutrition in oncology emphasise the usefulness of early assessment of nutritional status for a prompt identification of malnutrition and the implementation of effective interventions, but no real-world clinical data are available on the adequate management of nutritional support in patients with cancer in Italy.Methods and analysis This is an observational, longitudinal, multicentre registry of patients with a new diagnosis of cancer or metastatic disease, candidates for active treatment. They will be identified in at least 15 Italian oncological centres, members of the Alliance Against Cancer Working Group ‘Survivorship Care and Nutritional Support’. At least 1500 patients with cancer are expected to be enrolled each year. Detailed clinical and nutritional data will be collected by oncologists and clinical nutritionists during the visits foreseen in the clinical practice, through an ad hoc developed digital platform (e-Nutracare). The effects of malnutrition and nutritional support—at diagnosis and during follow-up—on overall survival and progression-free survival, as well as on patients’ symptoms and QoL, will be investigated.Ethics and dissemination The study protocol was approved by the Ethics Committee of the Fondazione IRCCS Policlinico San Matteo, Pavia, Italy and from the Ethics Committees of all other participating centres. An informed consent will be obtained from each patient enrolled in the study. Study findings will be disseminated through peer-reviewed journals, conferences and patients with cancer or professional associations. The registry will allow a better monitoring of the nutritional status of patients with cancer, promoting adequate and sustainable nutritional support, with the ultimate goal of improving the care and prognosis of these patients.https://bmjopen.bmj.com/content/13/8/e071858.full |
| spellingShingle | Paolo Pedrazzoli Sandro Pignata Patrizia Serra Francesco De Lorenzo Elisabetta Iannelli Toni Ibrahim Cristina Bosetti Carmine Pinto Valentina Da Prat Riccardo Caccialanza Vittorina Zagonel Filippo Montemurro Renato Cannizzaro Cristina Fortes Emanuele Cereda Alessandra Ferrari Stefania Gori Marco Tonello Francesco Serra Amanda Casirati Sara Masi Silvia Crotti Lorenzo Perrone Claudia Santucci Valentina Casalone Rosalisa Cici Giovanni De Pergola Teresa Di Lauro Iannelli Elisabetta Alessandra Longhi Cristina Mele Maria Roberto Mele Teresa Nardi Maria Debora Pezzuolo Carmelo Pozzo Lupe Sanchez Mete Guseppe Sukkar Samir Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) BMJ Open |
| title | Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) |
| title_full | Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) |
| title_fullStr | Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) |
| title_full_unstemmed | Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) |
| title_short | Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO) |
| title_sort | multicentric observational longitudinal study for the evaluation of nutritional management implications in newly diagnosed italian cancer patients the italian registry of malnutrition in oncology irmo |
| url | https://bmjopen.bmj.com/content/13/8/e071858.full |
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