Cancer, Cancer Metastatic
Conditions
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.
Interventions
OTHERCohort observational
Cohort observational
Sponsors
Istituto Di Ricerche Farmacologiche Mario Negri
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | Percentage of patients who are alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactRiccardo Caccialanza
Backup ContactCristina Bosetti
Outcome results
None listed