Preoperative Nutritional Support in Malnutritional Cancer Patients

Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Malnutrition; Biliary Cancer
• Intervention / Treatment: Dietary supplement: nutritional support program

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer

2. Patients diagnosed with malnutrition (at least more than one)

   1. PG-SGA B or C
   2. Weight loss >10% within 6 month
   3. BMI <18.5
   4. Serum Albumin <3.0
3. Age less than 80 years old over 20 years old
4. Performance status (ECOG scale): 0-1

5. Adequate organ functions

   1. Hb ≥7.0 g/dl
   2. ANC ≥1,500/mm3
   3. PLT ≥80,000/mm3
   4. Liver function: AST/ALT ≤5×upper limit of normal
   5. Creatinine ≤2.0 ULN

Exclusion Criteria:

1. Biopsy, drainage tube insertion, and other minor surgery
2. palliative surgery

3. Serious illness or medical conditions, as follows;

   1. congestive heart failure (NYHA class III or IV)
   2. unstable angina or myocardial infarction within the past 6 months,
   3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
   4. uncontrolled hypertension
   5. hepatic cirrhosis( ≥ Child class B)
   6. interstitial pneumonia, pulmonary adenomatosis
   7. psychiatric disorder that may interfere with and/or protocol compliance
   8. unstable diabetes mellitus
   9. uncontrolled ascites or pleural effusion
   10. active infection
4. Pregnancy
5. Any patients judged by the investigator to be unfit to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nutritional support program apply; Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.	Dietary supplement: 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
No Intervention: historical control group; Historical control group is that did not receiving

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complication	expected the duration of hospital stay of postoperation is 4~6 weeks.	at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative hospital stay	expected the duration of hospital stay of postoperation is 4~6 weeks.	expected the duration of hospital stay of postoperation is 4~6 weeks.
quality of life	preoperative, postoperative 14days	preoperative, postoperative 14days
postoperative cost( + nutritional support cost)	expected the duration of hospital stay of postoperation is 4~6 weeks.	at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
immunologic change(CD4/CD8) after nutritional support	CD4/CD8, immunoglobulin G, M, A	preoperative, postoperative 14days

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Collaborators: Fresenius Kabi
• Investigators: Principal Investigator: SangJae Park, National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 27, 2013
• Study Completion (Actual): April 5, 2017

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: December 7, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: nutrition; malnutrition; nutritional support; hepatobiliary pancreatic cancer; hepatobiliary pancreatic surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Nutrition Disorders; Pancreatic Diseases; Pancreatic Neoplasms; Malnutrition
• Other Study ID Numbers: NCCCTS-13-676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO