Nutrition for Colorectal Cancer Patients and Neutrophil Functions

NCT01831310 | Completed Phase 4

• 2 other identifiers: Canturkz1KOUNutrition1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Hypercatabolism and immune suppression are frequently seen in patients with malignancy. Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response. In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa. There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.

Conditions

Malnutrition; Colorectal Cancer

Keywords

Colorectal cancer; nutrition; neutrophil phagocytosis; neutrophil adhesivity; glutamine; omega 3 fatty acids

Outcome Measures

Primary Outcomes (1)

• neutrophil functions

  For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.

  perioperative,postoperative third and seventh days for change in first seven days of hospital stay

Secondary Outcomes (1)

• Length of stay

  Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.

Study Arms (4)

Control (standard) (Kabiven)

ACTIVE COMPARATOR

an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven)

Dietary Supplement: Standard (Kabiven)

Standard parenteral-glutamine (S-D)

EXPERIMENTAL

alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),

Dietary Supplement: Standard-Glutamine

Standard-Omega-3 fatty acid (S-O)

EXPERIMENTAL

Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)

Dietary Supplement: Standard-Omega 3 fatty acid

Standard-glutamine-omega 3 (S-D-O)

EXPERIMENTAL

ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).

Dietary Supplement: Standard-glutamine-omega 3

Interventions

Standard (Kabiven) DIETARY_SUPPLEMENT

Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Control (standard) (Kabiven)

Standard-Glutamine DIETARY_SUPPLEMENT

Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. it was 0.3-0.4 g/kg/day for glutamine dipeptide (Dipeptiven) supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Also known as: Standard (Kabiven)-Glutamine (Dipeptiven)

Standard parenteral-glutamine (S-D)

Standard-Omega 3 fatty acid DIETARY_SUPPLEMENT

Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven)supplementation was 0.1-0.2 g/kg /day. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Also known as: Standard (Kabiven)-Omega 3 fatty acid(Omegaven)

Standard-Omega-3 fatty acid (S-O)

Standard-glutamine-omega 3 DIETARY_SUPPLEMENT

Parenteral nutrition (kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven) supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide (dipeptiven)supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line

Also known as: Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven)

Standard-glutamine-omega 3 (S-D-O)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Colorectal cancer patients who were included study were between 50 and 70 years old

You may not qualify if:

• preoperatively suffered from serious comorbid chronic disease and received chemotherapy and radiotherapy
• immunosuppressive and /or immunomodulator drugs in last 6 months

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malnutrition; Colorectal Neoplasms

Interventions

alanylglutamine; fish oil triglycerides

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mustafa Dulger, Professor

  Kocaeli University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Surgical Oncology and head of Nutrition Team

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 15, 2013
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

TU (1)