NCT03926715

Brief Summary

Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2018

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

March 17, 2018

Last Update Submit

April 23, 2019

Conditions

MalnutritionSurgeryCancer

Keywords

MalnutritionPost-operative complication

Outcome Measures

Primary Outcomes (1)

  • Malnutrition

    Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)

    Pre-operative

Secondary Outcomes (1)

  • Post-operative complications

    Hospital discharge (10-15 days)

Interventions

Nutritional statusOTHER

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)

You may qualify if:

  • Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
  • Diagnosis of malignant solid tumor
  • Age\> 18 years
  • Informed consent

You may not qualify if:

  • Uncontrolled metabolic disorders
  • Uncompensated heart failure
  • Severe psychiatric disorders
  • Appropriate logistical support for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pof. Romario Fumagalli

Brescia, Italy

RECRUITING

Leonardo De Meo

Catania, Italy

RECRUITING

Claudio Pedrazzi

Reggio Emilia, Italy

RECRUITING

Roberto Coppola

Rome, 00198, Italy

RECRUITING

Antonio Gasbarrini

Rome, Italy

RECRUITING

Roberto Caronna

Rome, Italy

RECRUITING

Amilcare Parisi

Terni, Italy

RECRUITING

Giovanni de Manzoni

Verona, Italy

RECRUITING

Related Publications (9)

  • Garcia GH, Fu MC, Dines DM, Craig EV, Gulotta LV. Malnutrition: a marker for increased complications, mortality, and length of stay after total shoulder arthroplasty. J Shoulder Elbow Surg. 2016 Feb;25(2):193-200. doi: 10.1016/j.jse.2015.07.034. Epub 2015 Oct 9.

    PMID: 26456427RESULT

  • Culebras JM. Malnutrition in the twenty-first century: an epidemic affecting surgical outcome. Surg Infect (Larchmt). 2013 Jun;14(3):237-43. doi: 10.1089/sur.2013.9993. Epub 2013 May 15. No abstract available.

    PMID: 23676121RESULT

  • Mahdi H, Jernigan AM, Aljebori Q, Lockhart D, Moslemi-Kebria M. The impact of obesity on the 30-day morbidity and mortality after surgery for endometrial cancer. J Minim Invasive Gynecol. 2015 Jan;22(1):94-102. doi: 10.1016/j.jmig.2014.07.014. Epub 2014 Jul 24.

    PMID: 25064420RESULT

  • Hebuterne X, Lemarie E, Michallet M, de Montreuil CB, Schneider SM, Goldwasser F. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN J Parenter Enteral Nutr. 2014 Feb;38(2):196-204. doi: 10.1177/0148607113502674.

    PMID: 24748626RESULT

  • Ejaz A, Spolverato G, Kim Y, Poultsides GA, Fields RC, Bloomston M, Cho CS, Votanopoulos K, Maithel SK, Pawlik TM. Impact of body mass index on perioperative outcomes and survival after resection for gastric cancer. J Surg Res. 2015 May 1;195(1):74-82. doi: 10.1016/j.jss.2014.12.048. Epub 2014 Dec 31.

    PMID: 25619462RESULT

  • Muscaritoli M, Molfino A, Gioia G, Laviano A, Rossi Fanelli F. The "parallel pathway": a novel nutritional and metabolic approach to cancer patients. Intern Emerg Med. 2011 Apr;6(2):105-12. doi: 10.1007/s11739-010-0426-1. Epub 2010 Jul 2.

    PMID: 20596799RESULT

  • Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.

    PMID: 25799486RESULT

  • 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: 21296615RESULT

  • 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: 20060626RESULT

MeSH Terms

Conditions

MalnutritionNeoplasms

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Roberto Coppola

    Campus Bio-Medico of Rome

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maurizio Muscaritoli

CONTACT

(+39) 06 845431segreteria@sinuc.it

Simona Saracco

CONTACT

(+39) 06 845431

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2018

First Posted

April 24, 2019

Study Start

January 6, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations

IT(8)