The Italian Registry of Malnutrition in Oncology

NCT06337019 — Recruiting, 1500 participants, Fondazione IRCCS Policlinico San Matteo di Pavia

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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)

Registry	NCT06337019, acronym IRMO
Status	Recruiting
Study type	Observational
Enrollment	1500 (Estimated)
Sponsor	Fondazione IRCCS Policlinico San Matteo di Pavia (Other); collaborators: Istituto Di Ricerche Farmacologiche Mario Negri
Conditions	Cancer, Cancer Metastatic
Interventions	Cohort observational (Other)
Dates	start 2022-10-25, primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2024-03-29, last updated 2024-04-03
Locations	16 sites in Italy

-Summary

The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL.

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+Detailed description

This is a multicentric longitudinal observational study on a cohort of newly diagnosed cancer patients, candidate for active treatment. In Italy, no reliable data are still available with regards to the actual implementation of adequate nutritional support management in cancer patients; only "real-world" data collected by administrative databases are available in the context of nutrition in oncology, and this somehow limits the possibility to interpret the evidence from a clinical point of view. Hence, the purpose of the intestigators is to collect "real world" clinical data on malnutrition in oncology at the national level, in order to strengthen the evidence and concretely improve nutritional care practices in oncology.

+Arms and interventions

Arm	Type	Interventions	Description
Cohort observational		Other: Cohort observational	Overall study cohort

Cohort observational (Other): Cohort observational

+Outcome measures

Primary outcomes

Overall survival [1 year]: Percentage of patients who are alive.

Secondary outcomes

Progression-free survival [1 year and 2 years]: Percentage of patients who are free from tumor progression.
Treatment toxicity [1 year]: Treatment-related severe adverse event (grade > or =3) according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) and toxicity resulting in any treatment delay or dose reduction.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Aged ≥18 years;
* New diagnosis of the following cancers: head and neck, oesophagus/stomach, colorectal, hepato-biliary, pancreatic, lung, prostate, other urogenital, breast, gynaecological and, soft tissue sarcomas and melanomas; patients with a new diagnosis of metastatic disease will be also included;
* Eligible for active treatment;
* Written informed consent to participate in the study.

Exclusion Criteria:

* Impossibility to undertake the expected measurements;
* Impossibility to guarantee the attendance of the follow-up visits.

+Locations (16)

Facility	City	Country	Status
IRCCS Istituto Tumori Giovanni Paolo II,	Bari, BA	Italy	Not yet recruiting
IRCCS Saverio De Bellis	Castellana Grotte, BA	Italy	Recruiting
Istituto Ortopedico Rizzoli	Bologna, BO	Italy	Recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS	Meldola, FC	Italy	Recruiting
IRCCS Ospedale Policlinico San Martino	Genova, GE	Italy	Not yet recruiting
IRCCS Ospedale San Raffaele, Milano	Milan, MI	Italy	Recruiting
Centro di Riferimento Oncologico	Aviano, PN	Italy	Recruiting
IOV Istituto Oncologico Veneto	Padova, PV	Italy	Recruiting
AUSL IRCCS Reggio-Emilia	Reggio Emilia, RE	Italy	Recruiting
IDI IRCCS - Istituto Dermopatico dell'Immacolata	Roma, RM	Italy	Recruiting
Istituto Nazionale Tumori Regina Elena	Roma, RM	Italy	Recruiting
Policlinico Universitario Agostino Gemelli	Roma, RM	Italy	Recruiting
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS	Candiolo, TO	Italy	Recruiting
IRCCS Sacro Cuore Don Calabria	Negrar, VR	Italy	Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Naples	Italy	Not yet recruiting
Fondazione IRCCS Policlinico San Matteo, Pavia	Pavia	Italy	Recruiting

+Publications

Caccialanza R, De Lorenzo F, Gianotti L, Zagonel V, Gavazzi C, Farina G, Cotogni P, Cinieri S, Cereda E, Marchetti P, Nardi M, Iannelli E, Santangelo C, Traclo F, Pinto C, Pedrazzoli P. Nutritional support for cancer patients: still a neglected right? Support Care Cancer. 2017 Oct;25(10):3001-3004. doi: 10.1007/s00520-017-3826-1. Epub 2017 Jul 14. No abstract available. PMID 28710645
Caccialanza R, Goldwasser F, Marschal O, Ottery F, Schiefke I, Tilleul P, Zalcman G, Pedrazzoli P. Unmet needs in clinical nutrition in oncology: a multinational analysis of real-world evidence. Ther Adv Med Oncol. 2020 Feb 14;12:1758835919899852. doi: 10.1177/1758835919899852. eCollection 2020. PMID 32110247
Pedrazzoli P, Caccialanza R, Cotogni P, Degli Esposti L, Perrone V, Sangiorgi D, Di Costanzo F, Gavazzi C, Santoro A, Pinto C. The Advantages of Clinical Nutrition Use in Oncologic Patients in Italy: Real World Insights. Healthcare (Basel). 2020 May 6;8(2):125. doi: 10.3390/healthcare8020125. PMID 32384639

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