Preoperative Nutritional Support in Malnutritional Cancer Patients

NCT02626195 | Completed

• 1 other identifier: NCCCTS-13-676
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Biliary Cancer; Malnutrition

Keywords

malnutrition; nutrition; nutritional support; hepatobiliary pancreatic cancer; hepatobiliary pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

  at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)

Other Outcomes (1)

• immunologic change(CD4/CD8) after nutritional support

  preoperative, postoperative 14days

Study Arms (2)

nutritional support program apply

EXPERIMENTAL

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

Dietary Supplement: nutritional support program

historical control group

NO INTERVENTION

Historical control group is that did not receiving

Interventions

nutritional support program 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

nutritional support program apply

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Fresenius Kabi: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• SangJae Park

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: December 10, 2015
• Study Start: October 1, 2013
• Primary Completion: November 27, 2013
• Study Completion: April 5, 2017
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)