Clinical trial NCT02626195: Preoperative Nutritional Support in Malnutritional Cancer Patients
Official title: Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Biliary Cancer
Malnutrition
Keywords: malnutrition
nutrition
nutritional support
hepatobiliary pancreatic cancer
hepatobiliary pancreatic surgery
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Fresenius Kabi
First posted: 2015-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: postoperative complication
timeFrame: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
Secondary outcomes:
measure: postoperative hospital stay
timeFrame: expected the duration of hospital stay of postoperation is 4~6 weeks.
measure: quality of life
timeFrame: preoperative, postoperative 14days
measure: postoperative cost( + nutritional support cost)
timeFrame: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
Other outcomes:
measure: immunologic change(CD4/CD8) after nutritional support
timeFrame: preoperative, postoperative 14days
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: SangJae Park
role: PRINCIPAL_INVESTIGATOR
References: