Preoperative Nutritional Support in Malnutritional Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:

Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626195
• Other study ID #: NCCCTS-13-676
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: April 5, 2017

Study information

• Verified date: June 2018
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 5, 2017
• Est. primary completion date: November 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Cancer
• Malnutrition
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Fresenius Kabi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	immunologic change(CD4/CD8) after nutritional support	CD4/CD8, immunoglobulin G, M, A	preoperative, postoperative 14days
Primary	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	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.
Secondary	quality of life	preoperative, postoperative 14days	preoperative, postoperative 14days
Secondary	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.)