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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


Phase 4
50 Years
70 Years
Not Enrolling
Both
Malnutrition, Colorectal Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

neutrophil functions

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Mustafa Dulger, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Kocaeli University

Authority:

Turkey: Ministry of Health

Study ID:

Canturkz1

NCT ID:

NCT01831310

Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

  • Malnutrition
  • Colorectal Cancer
  • Colorectal cancer
  • nutrition
  • neutrophil phagocytosis
  • neutrophil adhesivity
  • glutamine
  • omega 3 fatty acids
  • Colorectal Neoplasms
  • Malnutrition

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