Prevalence of Malnutrition in Surgery

Cancer Clinical Trial

— PROMIS  

Official title:

Prevalence of Malnutrition in Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926715
• Other study ID #: 01
• Status: Recruiting
• Start date: January 6, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Società Italiana di Nutrizione Clinica e Metabolismo
• Contact: Maurizio Muscaritoli
• Phone: (+39) 06 845431
• Email: segreteria[@]sinuc.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Nutritional disorders are highly prevalent in cancer patients and have shown to contribute significantly in short-, mid- and long-term clinical outcome. The prevalence of malnutrition is reported between 25% and over 70% based on nutritional assessments. Nutritional disorders represent an important risk factor for the occurence of postoperative complications.

Main obstacles to improving nutritional care include lack of awareness for the problem among the general public and lack of awareness among decision makers and even care providers.

Considering the high prevalence of malnutrition and its repercussions in patient morbidity-mortality and healthcare cost, nutritional screening measures must be included in an integrated nutritional care plan for patients before surgery and while in the hospital.

The PRoMiS study was conceived to quantify nutritional disorders among gastrointestinal cancer patients undergoing surgery in Italy. The data obtained will contribute to increase the awareness of nutritional disorders among oncology surgical patients and their impact on clinical outcome, favoring the inclusion of the initial assessment of nutritional status before surgery and of the nutritional intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Uncontrolled metabolic disorders

• Uncompensated heart failure

• Severe psychiatric disorders

• Appropriate logistical support for participation in the study.

Related Conditions & MeSH terms

• Cancer
• Malnutrition
• Surgery

Intervention

Other:
• Nutritional status

Locations

Country	Name	City	State
Italy	Pof. Romario Fumagalli	Brescia
Italy	Leonardo De Meo	Catania
Italy	Claudio Pedrazzi	Reggio Emilia
Italy	Antonio Gasbarrini	Rome
Italy	Roberto Caronna	Rome
Italy	Roberto Coppola	Rome
Italy	Amilcare Parisi	Terni
Italy	Giovanni de Manzoni	Verona

Sponsors (4)

Lead Sponsor	Collaborator
Società Italiana di Nutrizione Clinica e Metabolismo	Campus Bio-Medico University, Catholic University of the Sacred Heart, University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. do — View Citation

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 ca — View Citation

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 — View Citation

Hébuterne X, Lemarié 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. — View Citation

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 J — View Citation

Muscaritoli M, Anker SD, Argilés 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-cachexi — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malnutrition	Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)	Pre-operative
Secondary	Post-operative complications	Incidence of pneumonia, sepsis and dehiscence of the surgical wound.	Hospital discharge (10-15 days)