Prevalence of Malnutrition in Oncology (PreMiO)

NCT01622036 | Completed

• 1 other identifier: MM-SL-PreMIO
• Study Type: observational
• Target: 1,978
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Pre-cachexia; Cancer

Keywords

Malnutrition; pre-cachexia; cancer; cachexia; MNA; weight loss

Outcome Measures

Primary Outcomes (1)

• Malnutrition

  Malnutrition will be assessed by Mini Nutritional Assessment, biochemical analysis and diagnostic criteria of pre-cachexia.

  Assessed at the first medical oncology visit

Secondary Outcomes (1)

• Anorexia

  Assessed at the first medical oncology visit

Study Arms (1)

Cancer patients undergoing first medical oncology visit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, 00185, Italy

Location

Related Publications (11)

• Muscaritoli M, Bossola M, Aversa Z, Bellantone R, Rossi Fanelli F. Prevention and treatment of cancer cachexia: new insights into an old problem. Eur J Cancer. 2006 Jan;42(1):31-41. doi: 10.1016/j.ejca.2005.07.026. Epub 2005 Nov 28.

  PMID: 16314085 RESULT

• Laviano A, Meguid MM, Rossi-Fanelli F. Cancer anorexia: clinical implications, pathogenesis, and therapeutic strategies. Lancet Oncol. 2003 Nov;4(11):686-94. doi: 10.1016/s1470-2045(03)01247-6.

  PMID: 14602249 RESULT

• Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.

  PMID: 19342610 RESULT

• Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.

  PMID: 7424938 RESULT

• Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

  PMID: 21296615 RESULT

• Muscaritoli M, Anker SD, Argiles J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8.

  PMID: 20060626 RESULT

• Lennard-Jones JE, Arrowsmith H, Davison C, Denham AF, Micklewright A. Screening by nurses and junior doctors to detect malnutrition when patients are first assessed in hospital. Clin Nutr. 1995 Dec;14(6):336-40. doi: 10.1016/s0261-5614(95)80050-6.

  PMID: 16843954 RESULT

• Muscaritoli M, Molfino A, Lucia S, Rossi Fanelli F. Cachexia: a preventable comorbidity of cancer. A T.A.R.G.E.T. approach. Crit Rev Oncol Hematol. 2015 May;94(2):251-9. doi: 10.1016/j.critrevonc.2014.10.014. Epub 2014 Nov 7.

  PMID: 25468676 RESULT

• Muscaritoli M, Aversa Z, Lucia S. The conundrum of pre-cachexia existence. Clin Nutr. 2014 Dec;33(6):1160. doi: 10.1016/j.clnu.2014.09.024. No abstract available.

  PMID: 25453398 RESULT

• Lucia S, Esposito M, Rossi Fanelli F, Muscaritoli M. Cancer cachexia: from molecular mechanisms to patient's care. Crit Rev Oncog. 2012;17(3):315-21. doi: 10.1615/critrevoncog.v17.i3.90.

  PMID: 22831162 RESULT

• Gioulbasanis I, Baracos VE, Giannousi Z, Xyrafas A, Martin L, Georgoulias V, Mavroudis D. Baseline nutritional evaluation in metastatic lung cancer patients: Mini Nutritional Assessment versus weight loss history. Ann Oncol. 2011 Apr;22(4):835-841. doi: 10.1093/annonc/mdq440. Epub 2010 Oct 11.

  PMID: 20937647 RESULT

MeSH Terms

Conditions

Malnutrition; Neoplasms; Cachexia; Weight Loss

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associated Professor

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

IT (1)