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Preoperative Nutritional Support in Malnutritional Cancer Patients

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Completed
CT.gov ID
NCT02626195
Collaborator
Fresenius Kabi (Industry)
50
Enrollment
1
Location
2
Arms
42.1
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: nutritional support program
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 27, 2013
Actual Study Completion Date :
Apr 5, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. postoperative complication [at discharge. (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 Outcome Measures

  1. 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.

  2. quality of life [preoperative, postoperative 14days]

    preoperative, postoperative 14days

  3. postoperative cost( + nutritional support cost) [at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)]

    expected the duration of hospital stay of postoperation is 4~6 weeks.

Other Outcome Measures

  1. immunologic change(CD4/CD8) after nutritional support [preoperative, postoperative 14days]

    CD4/CD8, immunoglobulin G, M, A

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer

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

  3. PG-SGA B or C

  4. Weight loss >10% within 6 month

  5. BMI <18.5

  6. Serum Albumin <3.0

  7. Age less than 80 years old over 20 years old

  8. Performance status (ECOG scale): 0-1

  9. Adequate organ functions

  10. Hb ≥7.0 g/dl

  11. ANC ≥1,500/mm3

  12. PLT ≥80,000/mm3

  13. Liver function: AST/ALT ≤5×upper limit of normal

  14. 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;

  4. congestive heart failure (NYHA class III or IV)

  5. unstable angina or myocardial infarction within the past 6 months,

  6. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block

  7. uncontrolled hypertension

  8. hepatic cirrhosis( ≥ Child class B)

  9. interstitial pneumonia, pulmonary adenomatosis

  10. psychiatric disorder that may interfere with and/or protocol compliance

  11. unstable diabetes mellitus

  12. uncontrolled ascites or pleural effusion

  13. active infection

  14. Pregnancy

  15. Any patients judged by the investigator to be unfit to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Center Goyang-si Gyeonggi-do Korea, Republic of 410-769

Sponsors and Collaborators

  • National Cancer Center, Korea
  • Fresenius Kabi

Investigators

  • Principal Investigator: SangJae Park, National Cancer Center, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sang-Jae Park, Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT02626195
Other Study ID Numbers:
  • NCCCTS-13-676
First Posted:
Dec 10, 2015
Last Update Posted:
Jun 11, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Sang-Jae Park, Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch, National Cancer Center, Korea
malnutrition
nutrition
nutritional support
hepatobiliary pancreatic cancer
hepatobiliary pancreatic surgery
Additional relevant MeSH terms:
Pancreatic Neoplasms
Malnutrition

Study Results

No Results Posted as of Jun 11, 2018