Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Nutritional Support in Malnutritional Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02626195
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Sang-Jae Park, National Cancer Center, Korea

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
Pancreatic Cancer Biliary Cancer Malnutrition Dietary Supplement: nutritional support program Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : November 27, 2013
Actual Study Completion Date : April 5, 2017


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



Primary Outcome Measures :
  1. postoperative complication [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: preoperative, postoperative 14days ]
    preoperative, postoperative 14days

  3. postoperative cost( + nutritional support cost) [ Time Frame: 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 [ Time Frame: preoperative, postoperative 14days ]
    CD4/CD8, immunoglobulin G, M, A



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626195


Locations
Layout table for location information
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Fresenius Kabi
Investigators
Layout table for investigator information
Principal Investigator: SangJae Park National Cancer Center, Korea

Layout table for additonal information
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     History of Changes
Other Study ID Numbers: NCCCTS-13-676
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sang-Jae Park, National Cancer Center, Korea:
malnutrition
nutrition
nutritional support
hepatobiliary pancreatic cancer
hepatobiliary pancreatic surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Malnutrition
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Nutrition Disorders