The Italian Registry of Malnutrition in Oncology (IRMO)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Cancer Metastatic
• Intervention / Treatment: Other: Cohort observational

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Riccardo Caccialanza; Phone Number: +39 0382501615; Email: r.caccialanza@smatteo.pv.it
• Study Contact Backup: Name: Cristina Bosetti; Email: cristina.bosetti@marionegri.it

Study Locations

• Italy
  • Napoli, Italy
    • Not yet recruiting
    • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
    • Contact: Vincenzo Quagliariello
  • Pavia, Italy
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo, Pavia
    • Contact: Riccardo Caccialanza
    • Contact: Paolo Pedrazzoli
  • BA
    • Bari, BA, Italy
      • Not yet recruiting
      • IRCCS Istituto Tumori Giovanni Paolo II,
      • Contact: Antonella Daniele
    • Castellana Grotte, BA, Italy
      • Recruiting
      • Irccs Saverio de Bellis
      • Contact: Giovanni de Pergola
      • Contact: Rosalisa Cici
  • BO
    • Bologna, BO, Italy
      • Recruiting
      • Istituto Ortopedico Rizzoli
      • Contact: Alessandra Longhi
      • Contact: Toni Ibrahim
  • FC
    • Meldola, FC, Italy
      • Recruiting
      • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS
      • Contact: Patrizia Serra
  • GE
    • Genova, GE, Italy
      • Not yet recruiting
      • IRCCS Ospedale Policlinico San Martino
      • Contact: Samir Guseppe Sukkar
  • MI
    • Milano, MI, Italy
      • Recruiting
      • IRCCS Ospedale San Raffaele, Milano
      • Contact: Roberto Mele
  • PN
    • Aviano, PN, Italy
      • Recruiting
      • Centro Di Riferimento Oncologico
      • Contact: Renato Cannizzaro
  • PV
    • Padova, PV, Italy
      • Recruiting
      • IOV Istituto Oncologico Veneto
      • Contact: Maria Teresa Nardi
      • Contact: Marco Tonello
  • RE
    • Reggio Emilia, RE, Italy
      • Recruiting
      • AUSL IRCCS Reggio-Emilia
      • Contact: Debora Pezzuolo
  • RM
    • Roma, RM, Italy
      • Recruiting
      • IDI IRCCS - Istituto Dermopatico dell'Immacolata
      • Contact: Cristina Fortes
    • Roma, RM, Italy
      • Recruiting
      • Istituto Nazionale Tumori Regina Elena
      • Contact: Lupe Sanchez Mete
    • Roma, RM, Italy
      • Recruiting
      • Policlinico Universitario Agostino Gemelli
      • Contact: Carmelo Pozzo
      • Contact: Maria Cristina Mele
  • TO
    • Candiolo, TO, Italy
      • Recruiting
      • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
      • Contact: Filippo Montemurro
      • Contact: Valentina Casalone
  • VR
    • Negrar, VR, Italy
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria
      • Contact: Stefania Gori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort observational; Overall study cohort	Other: Cohort observational; Cohort observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Percentage of patients who are alive.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Percentage of patients who are free from tumor progression.	1 year and 2 years
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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Collaborators: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: IRMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data derived from the study are property of the Promoter, who will commit to sharing them with the Investigators of each participating centres and to publish the results of the study in order to give full and timely information to the scientific community. The results of the research could be communicated to third parties and made public in conferences by the Investigators after accordance with the Study Responsible, in compliance with the Ministerial Decree of 2.05.2006.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No