Nutrition for Colorectal Cancer Patients and Neutrophil Functions

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Malnutrition, Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Standard (Kabiven)
* Dietary Supplement: Standard-Glutamine
* Dietary Supplement: Standard-Omega 3 fatty acid
* Dietary Supplement: Standard-glutamine-omega 3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (standard) (Kabiven)<br>an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven) | Dietary Supplement: Standard (Kabiven)<br>* 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<br>|
| Experimental: Standard parenteral-glutamine (S-D)<br>alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8), | Dietary Supplement: Standard-Glutamine<br>* 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<br>* Other names: Standard (Kabiven)-Glutamine (Dipeptiven);|
| Experimental: Standard-Omega-3 fatty acid (S-O)<br>Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8) | Dietary Supplement: Standard-Omega 3 fatty acid<br>* 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<br>* Other names: Standard (Kabiven)-Omega 3 fatty acid(Omegaven);|
| Experimental: Standard-glutamine-omega 3 (S-D-O)<br>ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10). | Dietary Supplement: Standard-glutamine-omega 3<br>* 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<br>* Other names: Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, nutrition, neutrophil phagocytosis, neutrophil adhesivity, glutamine, omega 3 fatty acids