Nutrition for Colorectal Cancer Patients and Neutrophil Functions
Condition: Malnutrition; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Malnutrition
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): Standard (Kabiven); Standard-Glutamine; Standard-Omega 3 fatty acid; Standard-glutamine-omega 3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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; 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; 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; 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
Other intervention name(s): Standard (Kabiven)-Glutamine (Dipeptiven); Standard (Kabiven)-Omega 3 fatty acid(Omegaven); Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Colorectal cancer; nutrition; neutrophil phagocytosis; neutrophil adhesivity; glutamine; omega 3 fatty acids