NCT01789073

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

February 7, 2013

Last Update Submit

December 20, 2013

Conditions

Pancreatic Cancer

Keywords

PostoperativeComplicationsElectiveSurgeryGI surgeryImmunonutritionImmune-enhancingImmune-modulatingNutritionPancreatic cancerPostoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.

Outcome Measures

Primary Outcomes (1)

  • Overall postoperative complications after major gastrointestinal (GI) elective surgery.

    Within the first 30 days after surgery

Secondary Outcomes (1)

  • Length of hospital stay after major gastrointestinal (GI) elective surgery

    Within the first 30 days after surgery

Other Outcomes (1)

  • Weight stability, functional capability and patients´ satisfaction with the overall study course.

    from recruitment and within 30 days after surgery

Study Arms (2)

Oral Impact, Nestlé Health Science

EXPERIMENTAL

Oral Impact-arm receives the intervention the last 7 days prior to surgery

Dietary Supplement: Oral Impact, Nestlé Health Science

Control

NO INTERVENTION

The control-arm receives no intervention but is treated according to the standard procedures

Interventions

Oral Impact, Nestlé Health ScienceDIETARY_SUPPLEMENT

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.

Oral Impact, Nestlé Health Science

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer
  • Age \> 18 years.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Gastroenterology Clinic C, Ward 2122, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Gade J, Levring T, Hillingso J, Hansen CP, Andersen JR. The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial. Nutr Cancer. 2016;68(2):225-33. doi: 10.1080/01635581.2016.1142586. Epub 2016 Mar 4.

    PMID: 26943500DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens R Andersen, Chief Phys., Ass. Prof.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Institute of Human Nutrition

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 23, 2013

Record last verified: 2013-12

Locations

DK(1)