Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

Pancreatic Cancer Clinical Trial

Official title:

Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789073
• Other study ID #: H-1-2012-146
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: December 20, 2013
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: "The National Ethical Commitee under The Ministry of health and prevention".
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer

• Age > 18 years.

Exclusion Criteria:

• Age < 18 years

• Pregnant and lactating women

• Persons who cannot understand and/or speak Danish

• Renal dysfunction

• Milk allergy

• Participants are excluded if elective surgery is not indicated after all

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• Oral Impact, Nestlé Health Science
Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.

Locations

Country	Name	City	State
Denmark	Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight stability, functional capability and patients´ satisfaction with the overall study course.		from recruitment and within 30 days after surgery	No
Primary	Overall postoperative complications after major gastrointestinal (GI) elective surgery.		Within the first 30 days after surgery	No
Secondary	Length of hospital stay after major gastrointestinal (GI) elective surgery		Within the first 30 days after surgery	No