Clinical trial NCT01622036: Prevalence of Malnutrition in Oncology (PreMiO)
Official title: The PreMiO Study: The Prevalence of Malnutrition in Oncology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Pre-cachexia
Cancer
Keywords: Malnutrition
pre-cachexia
cancer
cachexia
MNA
weight loss
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 1978
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 and Islands).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients at first medical oncology visit
* diagnosis of solid tumor
* age \> 18 years
* no previous anticancer therapies (e.g. radiotherapy or chemotherapy)
* Life expectancy \>3 months according with PaP score
* Informed consent

Exclusion Criteria:

* Oral feeding incapacity or intestinal obstruction
* Decompensated metabolic disorders
* Severe liver failure (total bilirubin \>1.5 mg/dL (25μmol/L), and AST (SGOT)/ ALT (SGPT) \>2 x ULN or, in the case of metastatic liver, \> 5 x ULN) or severe kidney failure (creatinine \> 2.0 mg/dL (177 μmol/L), creatinine clearance ClCr \< 50ml/min).
* Acute Decompensated heart failure
* Active infection
* Primary brain tumors or metastatic brain tumors
* severe psychiatric disorders
* MMSE \< 25/30 (in patient aged \>70).
* Inadequate logistical support for the study participation.

Primary outcomes:
measure: Malnutrition
timeFrame: Assessed at the first medical oncology visit
Secondary outcomes:
measure: Anorexia
timeFrame: Assessed at the first medical oncology visit
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
References:
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