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Prevalence of Malnutrition in Oncology (PreMiO) (PreMiO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622036
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Maurizio Muscaritoli, University of Roma La Sapienza

Study Description
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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.


Condition or disease
Malnutrition Pre-cachexia Cancer

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Study Design
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Study Type : Observational
Actual Enrollment : 1978 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Groups and Cohorts
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Group/Cohort
Cancer patients undergoing first medical oncology visit.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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).
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
Sapienza University of Rome
Rome, Italy, 00185
Sponsors and Collaborators
University of Roma La Sapienza
More Information
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Publications of Results:

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Responsible Party: Maurizio Muscaritoli, MD, Associated Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01622036    
Other Study ID Numbers: MM-SL-PreMIO
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Maurizio Muscaritoli, University of Roma La Sapienza:
Malnutrition
pre-cachexia
cancer
 cachexia
MNA
weight loss
Additional relevant MeSH terms:
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Malnutrition
Wasting Syndrome
Cachexia
Nutrition Disorders
Weight Loss
 Body Weight Changes
Body Weight
Thinness
Metabolic Diseases