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Nutrition for Colorectal Cancer Patients and Neutrophil Functions

Primary Purpose

Malnutrition, Colorectal Cancer

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Standard (Kabiven)
Standard-Glutamine
Standard-Omega 3 fatty acid
Standard-glutamine-omega 3
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Colorectal cancer, nutrition, neutrophil phagocytosis, neutrophil adhesivity, glutamine, omega 3 fatty acids

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kocaeli University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Control (standard) (Kabiven)

Standard parenteral-glutamine (S-D)

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

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2013
Last Updated
April 10, 2013
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT01831310
Brief Title
Nutrition for Colorectal Cancer Patients and Neutrophil Functions
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Colorectal Cancer
Keywords
Colorectal cancer, nutrition, neutrophil phagocytosis, neutrophil adhesivity, glutamine, omega 3 fatty acids

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (standard) (Kabiven)
Arm Type
Active Comparator
Arm Description
an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven)
Arm Title
Standard parenteral-glutamine (S-D)
Arm Type
Experimental
Arm Description
alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),
Arm Title
Standard-Omega-3 fatty acid (S-O)
Arm Type
Experimental
Arm Description
Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)
Arm Title
Standard-glutamine-omega 3 (S-D-O)
Arm Type
Experimental
Arm Description
ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard (Kabiven)
Intervention Description
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
Intervention Name(s)
Standard-Glutamine
Other Intervention Name(s)
Standard (Kabiven)-Glutamine (Dipeptiven)
Intervention Description
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
Intervention Name(s)
Standard-Omega 3 fatty acid
Other Intervention Name(s)
Standard (Kabiven)-Omega 3 fatty acid(Omegaven)
Intervention Description
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
Intervention Name(s)
Standard-glutamine-omega 3
Other Intervention Name(s)
Standard (Kabiven)-glutamine (Dipeptiven)-omega 3 (Omegaven)
Intervention Description
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
Primary Outcome Measure Information:
Title
neutrophil functions
Description
For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
Time Frame
perioperative,postoperative third and seventh days for change in first seven days of hospital stay
Secondary Outcome Measure Information:
Title
Length of stay
Description
For comparison of four different nutrition on length of stay (participants will be followed for the duration of hospital 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Dulger, Professor
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Study Chair
Facility Information:
Facility Name
Kocaeli University School of Medicine
City
Kocaeli
ZIP/Postal Code
41300
Country
Turkey

12. IPD Sharing Statement

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Nutrition for Colorectal Cancer Patients and Neutrophil Functions

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