Nutrition for Colorectal Cancer Patients and Neutrophil Functions

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831310
• Other study ID #: Canturkz1
• Secondary ID: KOUNutrition1
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2013
• Last updated: April 10, 2013
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: April 2013
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Malnutrition

Intervention

Dietary Supplement:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Turkey	Kocaeli University School of Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Length of stay	For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital 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.	Yes