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The Italian Registry of Malnutrition in Oncology

ConditionsCancerCancer Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Impossibility to undertake the expected measurements;

Impossibility to guarantee the attendance of the follow-up visits.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cohort observational

    Other intervention

    Cohort observational

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Cohort observational1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Percentage of patients who are alive.

Time frame
1 year

Secondary outcomes

1

Progression-free survival

Percentage of patients who are free from tumor progression.

Time frame
1 year and 2 years
2

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Policlinico San Matteo di Pavia

Lead sponsor

Istituto Di Ricerche Farmacologiche Mario Negri

Collaborator

Source ClinicalTrials.gov
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