Prevalence of Malnutrition in Oncology (PreMiO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Maurizio Muscaritoli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01622036
First received: June 11, 2012
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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
Malnutrition
Pre-cachexia
Cancer

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The PreMiO Study: The Prevalence of Malnutrition in Oncology.

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Malnutrition [ Designated as safety issue: No ]
    Malnutrition will be assessed by Mini Nutritional Assessment, biochemical analysis and diagnostic criteria of pre-cachexia.


Secondary Outcome Measures:
  • Anorexia [ Designated as safety issue: No ]
    Anorexia will be assessed via a modified version of AC/S-12 FAACT, via Visual Analogue Scale and specific questionnaire.


Estimated Enrollment: 6000
Study Start Date: June 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cancer patients undergoing first medical oncology visit.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622036

Contacts
Contact: Maurizio Muscaritoli, MD +3906409972020 maurizio.muscaritoli@uniroma1.it

Locations
Italy
Sapienza University of Rome Recruiting
Rome, Italy, 00185
Contact: Maurizio Muscaritoli, MS    +3906409972016    maurizio.muscaritoli@uniroma1.it   
Principal Investigator: Maurizio Muscaritoli, MD         
Sub-Investigator: Simone Lucia, MD         
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Maurizio Muscaritoli, MD, Associated Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01622036     History of Changes
Other Study ID Numbers: MM-SL-PreMIO
Study First Received: June 11, 2012
Last Updated: June 13, 2012
Health Authority: Italy: National Bioethics Committee

Keywords provided by University of Roma La Sapienza:
Malnutrition
pre-cachexia
cancer
cachexia
MNA
weight loss

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014