Nutrition for Colorectal Cancer Patients and Neutrophil Functions

NCT ID: NCT01831310

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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.

Detailed Description

Purpose 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.

Condition Intervention Phase Malnutrition Colorectal Cancer Dietary Supplement: Immunonutrition Phase 4

Study Type: Interventional Study Design: Prevention, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, N/A

Official Title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study

Primary Outcome Measure: Title: neutrophil functions Time Frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay Description: For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.

Secondary Outcome Measures: Title: Length of stay Time Frame: 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.

Description: For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital stay)

Actual Enrollment: 36 Study Start Date: January 2007 Actual Study Completion Date: January 2008 Actual Primary Completion Date: January 2008

Arms Assigned Interventions Active Comparator: Control an isocaloric and iso-nitrogenous standard parenteral nutrition

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

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

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

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

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

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

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

Conditions

Malnutrition; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control (standard) (Kabiven)

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

Group Type: ACTIVE_COMPARATOR

Standard (Kabiven)

Intervention Type: 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

Standard parenteral-glutamine (S-D)

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

Group Type: EXPERIMENTAL

Standard-Glutamine

Intervention Type: 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

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

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

Group Type: EXPERIMENTAL

Standard-Omega 3 fatty acid

Intervention Type: 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

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

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

Group Type: EXPERIMENTAL

Standard-glutamine-omega 3

Intervention Type: 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

Interventions

Standard (Kabiven)

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

Intervention Type: DIETARY_SUPPLEMENT

Standard-Glutamine

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

Intervention Type: DIETARY_SUPPLEMENT

Standard-Omega 3 fatty acid

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

Intervention Type: DIETARY_SUPPLEMENT

Standard-glutamine-omega 3

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Standard (Kabiven)-Glutamine (Dipeptiven); Standard (Kabiven)-Omega 3 fatty acid(Omegaven); Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Nuh Zafer Cantürk

Professor in Surgical Oncology and head of Nutrition Team

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Dulger, Professor

Role: STUDY_CHAIR

Kocaeli University

Locations

Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOUNutrition1

Identifier Type: OTHER

Identifier Source: secondary_id

Canturkz1

Identifier Type: -

Identifier Source: org_study_id