Prevalence of Malnutrition in Oncology (PreMiO) (PreMiO)
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|ClinicalTrials.gov Identifier: NCT01622036|
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : December 3, 2015
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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.
|Condition or disease|
|Malnutrition Pre-cachexia Cancer|
|Study Type :||Observational|
|Actual Enrollment :||1978 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||The PreMiO Study: The Prevalence of Malnutrition in Oncology.|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||March 2015|
|Cancer patients undergoing first medical oncology visit.|
- Malnutrition [ Time Frame: Assessed at the first medical oncology visit ]Malnutrition will be assessed by Mini Nutritional Assessment, biochemical analysis and diagnostic criteria of pre-cachexia.
- Anorexia [ Time Frame: Assessed at the first medical oncology visit ]Anorexia will be assessed via a modified version of AC/S-12 FAACT, via Visual Analogue Scale and specific questionnaire.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622036
|Sapienza University of Rome|
|Rome, Italy, 00185|
|Responsible Party:||Maurizio Muscaritoli, MD, Associated Professor, University of Roma La Sapienza|
|Other Study ID Numbers:||
|First Posted:||June 18, 2012 Key Record Dates|
|Last Update Posted:||December 3, 2015|
|Last Verified:||December 2015|
Body Weight Changes