Clinical trial NCT06337019: The Italian Registry of Malnutrition in Oncology
Official 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cancer Metastatic
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: Istituto Di Ricerche Farmacologiche Mario Negri
First posted: 2024-03-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed adult cancer patients, candidate for active treatment consecutively identified in 12 Italian IRCCS members of the ACC WG "Survivorship Care e Supporto Nutrizionale". Identification of consecutive cancer patients can be done over two weeks a month only, for the centres with the higher patients' load.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 1 year and 2 years
measure: Treatment toxicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II,
state: BA
city: Castellana Grotte
country: Italy
facility: IRCCS Saverio De Bellis
state: BA
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS
state: FC
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: GE
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele, Milano
state: MI
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: PN
city: Padova
country: Italy
facility: IOV Istituto Oncologico Veneto
state: PV
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS Reggio-Emilia
state: RE
city: Roma
country: Italy
facility: IDI IRCCS - Istituto Dermopatico dell'Immacolata
state: RM
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: RM
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: RM
city: Candiolo
country: Italy
facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
state: TO
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria
state: VR
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Pavia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.