MalnutritionPreMiONCT01622036
Prevalence of Malnutrition in Oncology (PreMiO)
An observational study of Malnutrition and Pre-cachexia, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Pre-cachexia, Cancer
- How many people
- 1,978 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- severe psychiatric disorders
- MMSE < 25/30 (in patient aged >70).
- Inadequate logistical support for the study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PreMiO Study: The Prevalence of Malnutrition in Oncology.
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.
Read the 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.
- Conditions
- Malnutrition, Pre-cachexia, Cancer
- Keywords
- Malnutrition, pre-cachexia, cancer, cachexia, MNA, weight loss
- Medical subject headings
- Malnutrition, Neoplasms, Cachexia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients undergoing first medical oncology visit. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition
Malnutrition will be assessed by Mini Nutritional Assessment, biochemical analysis and diagnostic criteria of pre-cachexia.
Measured: Assessed at the first medical oncology visit
Secondary outcomes (1)
Anorexia
Anorexia will be assessed via a modified version of AC/S-12 FAACT, via Visual Analogue Scale and specific questionnaire.
Measured: Assessed at the first medical oncology visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,978 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Muscaritoli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622036
- Sponsor's protocol ID
- MM-SL-PreMIO
- Acronym
- PreMiO
- Status last verified
- Dec 2015
- First submitted
- 11 Jun 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16314085Laviano 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.
PubMed 14602249Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.
PubMed 19342610Dewys 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.
PubMed 7424938Fearon 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.
PubMed 21296615Muscaritoli 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.
PubMed 20060626Lennard-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.
PubMed 16843954Muscaritoli 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.
PubMed 25468676Muscaritoli 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.
PubMed 25453398Lucia 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.
PubMed 22831162Gioulbasanis 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.
PubMed 20937647
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PreMiO Study: The Prevalence of Malnutrition in Oncology.
- ClinicalTrials.gov ID
- NCT01622036
- Acronym / sponsor ID
- PreMiO / MM-SL-PreMIO
- Conditions
- Malnutrition, Pre-cachexia, Cancer
- Keywords
- Malnutrition, pre-cachexia, cancer, cachexia, MNA, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,978 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients undergoing first medical oncology visit. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Anorexia
Time frame: Assessed at the first medical oncology visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Results publication: PubMed 16314085Muscaritoli 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.
- Results publication: PubMed 14602249Laviano 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.
- Results publication: PubMed 19342610Tisdale MJ. Mechanisms of cancer cachexia. Physiol Rev. 2009 Apr;89(2):381-410. doi: 10.1152/physrev.00016.2008.
- Results publication: PubMed 7424938Dewys 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.
- Results publication: PubMed 21296615Fearon 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.
- Results publication: PubMed 20060626Muscaritoli 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.
- Results publication: PubMed 16843954Lennard-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.
- Results publication: PubMed 25468676Muscaritoli 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.
- Results publication: PubMed 25453398Muscaritoli 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.
- Results publication: PubMed 22831162Lucia 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.
- Results publication: PubMed 20937647Gioulbasanis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Pre-cachexia, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition (time frame: Assessed at the first medical oncology visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622036, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.