The Italian Registry of Malnutrition in Oncology

Cancer Clinical Trial

— IRMO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337019
• Other study ID #: IRMO
• Status: Recruiting
• Start date: October 25, 2022
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: Fondazione IRCCS Policlinico San Matteo di Pavia
• Contact: Riccardo Caccialanza
• Phone: +39 0382501615
• Email: r.caccialanza[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cancer Metastatic
• Malnutrition

Intervention

Other:
• Cohort observational
Cohort observational

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico	Aviano	PN
Italy	IRCCS Istituto Tumori Giovanni Paolo II,	Bari	BA
Italy	Istituto Ortopedico Rizzoli	Bologna	BO
Italy	Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS	Candiolo	TO
Italy	IRCCS Saverio De Bellis	Castellana Grotte	BA
Italy	IRCCS Ospedale Policlinico San Martino	Genova	GE
Italy	Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS	Meldola	FC
Italy	IRCCS Ospedale San Raffaele, Milano	Milano	MI
Italy	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli
Italy	IRCCS Sacro Cuore Don Calabria	Negrar	VR
Italy	IOV Istituto Oncologico Veneto	Padova	PV
Italy	Fondazione IRCCS Policlinico San Matteo, Pavia	Pavia
Italy	AUSL IRCCS Reggio-Emilia	Reggio Emilia	RE
Italy	IDI IRCCS - Istituto Dermopatico dell'Immacolata	Roma	RM
Italy	Istituto Nazionale Tumori Regina Elena	Roma	RM
Italy	Policlinico Universitario Agostino Gemelli	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia	Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Percentage of patients who are alive.	1 year
Secondary	Progression-free survival	Percentage of patients who are free from tumor progression.	1 year and 2 years
Secondary	Treatment toxicity	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.	1 year