Preoperative Nutritional Support in Malnutritional Cancer Patients

NCT ID: NCT02626195

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-04-05

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

Conditions

Pancreatic Cancer; Biliary Cancer; Malnutrition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nutritional support program apply

Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.

Group Type: EXPERIMENTAL

nutritional support program

Intervention Type: DIETARY_SUPPLEMENT

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

historical control group

Historical control group is that did not receiving

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sang-Jae Park

Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SangJae Park

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCCCTS-13-676

Identifier Type: -

Identifier Source: org_study_id