Cancer Clinical Trial
Official title:
The PreMiO Study: The Prevalence of Malnutrition in Oncology.
It is estimated that up to 30% of cancer patients die because of the effects of
malnutrition, caused by a discrepancy between nutritional needs and intake (or utilization)
of energy and essential nutrients. Malnutrition and its severe complication, cancer
cachexia, are negative prognostic factors in neoplastic patients, inducing Decreased
response and tolerance to antineoplastic treatments, decline in the functional status,
reduced quality of life and reduced survival. Prevalence data on malnutrition in italian
oncology patients are lacking and the available literature data on weight loss and
malnutrition in oncology refer to patients in different phases of disease and therapy. Most
importantly , strategies for prevention of malnutrition and cachexia in oncology are still
largely disregarded and scarcely implemented.
The main objective of this project is to assess the prevalence of malnutrition in patients
undergoing first medical oncology visit in Italy. Secondary objective is to increase
awareness of metabolic and nutritional issues among medical oncologists, thus favoring the
inclusion of metabolic-nutritional screening and monitoring in medical oncology protocols.
This would in turn contribute to reduce the negative consequences of malnutrition- and
cachexia-related complications.
The acronym of the project "PreMiO" means "Prevalence of Malnutrition in Oncology".
The project arises from the observation that the negative consequences of cancer-related
malnutrition and cachexia are still largely underestimated in most oncology units , both in
Europe and the USA. Indeed, the prevention and treatment of the nutritional and metabolic
sequelae of cancer and its treatment, are not perceived as a priority by most oncologists.
This is quite surprising, considering the body of evidence demonstrating that the
deterioration of the nutritional status adversely affects treatment response, morbidity,
quality of life and survival of cancer patients. In other words, malnourished or cachectic
cancer patients lose chances to be adequately treated for their underlying disease.
Approximately one quarter of all deaths in western society are due to cancer. Half of all
patients with cancer lose body weight; one third lose more than 5% of their original body
weight and up to 20% of all cancer deaths are caused directly by cachexia. The greatest
prevalence of weight loss is seen among patients with solid tumours: gastric, pancreatic,
lung, colorectal, and head and neck. The overall prevalence of weight loss in cancer
patients may rise as high as 86% in the last 1-2 weeks of life.The pathogenesis of weight
loss, malnutrition and cachexia in cancer is multifactorial and represent the result of the
complex interplay between the tumor, host's metabolism, tumor-derived and host-derived
humoral factors, and the negative consequences of anticancer treatments on the patient's
ability to assume, absorb and metabolize nutrients.
Objectives The objective of the PreMiO project is to obtain data on the prevalence of
malnutrition in Italian cancer patients undergoing the first medical oncology visit. The
project is innovative since an oncologist, not a nutrition specialist, will perform the
nutritional evaluation of the patients.
The data obtained will contribute to increase the awareness of metabolic and nutritional
problems in oncology, favoring the inclusion of the initial assessment and
nutritional-metabolic monitoring in oncological protocols.
Patients and Methods "PreMIO" will be a prospective, multicentre observational study,
designed to assess the nutritional status in cancer patients presenting for the first visit
to an oncological center. Enrollment will be conducted at Italian ESMO-accredited centers
and in other medical oncological centers in Italy. Six-thousand patients have been
considered an adequate sample for a suitable estimation of the prevalence of malnutrition in
Italian cancer patients at first medical oncology visit. Patient recruitment will be ensured
through enrollment by 60 centers throughout the Italian national territory (North, Center,
South). The instruments used for patients' evaluation will be the Mini Nutritional
Assessment ® (MNA ®) and the criteria for the diagnosis of pre-cachexia elaborated by ESPEN.
Pre-cachexia is a clinical condition characterized , in the context of a chronic disease
(i.e. cancer), by unintentional weigh loss ≤ 5% during last 6 months, chronic systemic
inflammation and anorexia or anorexia-related symptoms. Although other nutritional tools are
available for nutritional status evaluation (Nutritional Risk Screening 2002, NRS 2002;
Malnutrition Universal Screening Tool, MUST), even in oncological setting (Subjective Global
Assessment, SGA; Patient-Generated Subjective Global Assessment, PG-SGA), we choose MNA® for
its diagnostic sensitivity and its rapidity of administration. The MNA ® consists of a first
screening part and of a second part as global assessment, which allows to obtain a score
reflecting the patient nutritional status. Moreover, this instrument was recently considered
the best screening method of nutrition status in patients with metastatic lung cancer. The
data generated in each participating center will be collected by the Coordinator Centre
(IDI-IRCCS). Patients will be stratified according to cancer type and localization, disease
stage, age, sex, general condition. It is expected that the prevalence of malnutrition and
pre- cachexia will vary widely, depending on tumor type, localization, stage and previous
surgical treatment. Multivariate analysis will allow to discriminate among the factors
contributing to the occurrence and prevalence of malnutrition in the study population.
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Observational Model: Ecologic or Community, Time Perspective: Prospective
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