Back to resultsPreoperative Nutritional Support in Malnutritional Cancer Patients
Primary Purpose
Pancreatic Cancer, Biliary Cancer, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
nutritional support program
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring malnutrition, nutrition, nutritional support, hepatobiliary pancreatic cancer, hepatobiliary pancreatic surgery
Eligibility Criteria
Inclusion Criteria:
- Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
Patients diagnosed with malnutrition (at least more than one)
- PG-SGA B or C
- Weight loss >10% within 6 month
- BMI <18.5
- Serum Albumin <3.0
- Age less than 80 years old over 20 years old
- Performance status (ECOG scale): 0-1
Adequate organ functions
- Hb ≥7.0 g/dl
- ANC ≥1,500/mm3
- PLT ≥80,000/mm3
- Liver function: AST/ALT ≤5×upper limit of normal
- Creatinine ≤2.0 ULN
Exclusion Criteria:
- Biopsy, drainage tube insertion, and other minor surgery
- palliative surgery
Serious illness or medical conditions, as follows;
- congestive heart failure (NYHA class III or IV)
- unstable angina or myocardial infarction within the past 6 months,
- significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- uncontrolled hypertension
- hepatic cirrhosis( ≥ Child class B)
- interstitial pneumonia, pulmonary adenomatosis
- psychiatric disorder that may interfere with and/or protocol compliance
- unstable diabetes mellitus
- uncontrolled ascites or pleural effusion
- active infection
- Pregnancy
- Any patients judged by the investigator to be unfit to participate in the study
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
nutritional support program apply
historical control group
Arm Description
Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.
Historical control group is that did not receiving
Outcomes
Primary Outcome Measures
postoperative complication
expected the duration of hospital stay of postoperation is 4~6 weeks.
Secondary Outcome Measures
postoperative hospital stay
expected the duration of hospital stay of postoperation is 4~6 weeks.
quality of life
preoperative, postoperative 14days
postoperative cost( + nutritional support cost)
expected the duration of hospital stay of postoperation is 4~6 weeks.
Full Information
NCT ID
NCT02626195
First Posted
June 8, 2015
Last Updated
June 7, 2018
Sponsor
National Cancer Center, Korea
Collaborators
Fresenius Kabi
1. Study Identification
Unique Protocol Identification Number
NCT02626195
Brief Title
Preoperative Nutritional Support in Malnutritional Cancer Patients
Official Title
Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 27, 2013 (Actual)
Study Completion Date
April 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Fresenius Kabi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.
The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.
Detailed Description
This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).
For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
Calories: 30-35Kg, via enteral or parenteral
Protein: 1.2-1.5g/Kg
Lipid : 1-1.5g/Kg
Mineral and vitamins supply
Blood glucose control
Daily monitoring by dietician and specialized nurse
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Biliary Cancer, Malnutrition
Keywords
malnutrition, nutrition, nutritional support, hepatobiliary pancreatic cancer, hepatobiliary pancreatic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nutritional support program apply
Arm Type
Experimental
Arm Description
Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.
Arm Title
historical control group
Arm Type
No Intervention
Arm Description
Historical control group is that did not receiving
Intervention Type
Dietary Supplement
Intervention Name(s)
nutritional support program
Intervention Description
Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
Calories: 30-35Kg, via enteral or parenteral
Protein: 1.2-1.5g/Kg
Lipid : 1-1.5g/Kg
Mineral and vitamins supply
Blood glucose control
Daily monitoring by dietician and specialized nurse
Primary Outcome Measure Information:
Title
postoperative complication
Description
expected the duration of hospital stay of postoperation is 4~6 weeks.
Time Frame
at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
Secondary Outcome Measure Information:
Title
postoperative hospital stay
Description
expected the duration of hospital stay of postoperation is 4~6 weeks.
Time Frame
expected the duration of hospital stay of postoperation is 4~6 weeks.
Title
quality of life
Description
preoperative, postoperative 14days
Time Frame
preoperative, postoperative 14days
Title
postoperative cost( + nutritional support cost)
Description
expected the duration of hospital stay of postoperation is 4~6 weeks.
Time Frame
at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
Other Pre-specified Outcome Measures:
Title
immunologic change(CD4/CD8) after nutritional support
Description
CD4/CD8, immunoglobulin G, M, A
Time Frame
preoperative, postoperative 14days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
Patients diagnosed with malnutrition (at least more than one)
PG-SGA B or C
Weight loss >10% within 6 month
BMI <18.5
Serum Albumin <3.0
Age less than 80 years old over 20 years old
Performance status (ECOG scale): 0-1
Adequate organ functions
Hb ≥7.0 g/dl
ANC ≥1,500/mm3
PLT ≥80,000/mm3
Liver function: AST/ALT ≤5×upper limit of normal
Creatinine ≤2.0 ULN
Exclusion Criteria:
Biopsy, drainage tube insertion, and other minor surgery
palliative surgery
Serious illness or medical conditions, as follows;
congestive heart failure (NYHA class III or IV)
unstable angina or myocardial infarction within the past 6 months,
significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
uncontrolled hypertension
hepatic cirrhosis( ≥ Child class B)
interstitial pneumonia, pulmonary adenomatosis
psychiatric disorder that may interfere with and/or protocol compliance
unstable diabetes mellitus
uncontrolled ascites or pleural effusion
active infection
Pregnancy
Any patients judged by the investigator to be unfit to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SangJae Park
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Preoperative Nutritional Support in Malnutritional Cancer Patients
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