Preoperative Nutritional Support in Malnutritional Cancer Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02626195
Study type	Interventional
Source	National Cancer Center, Korea
Contact
Status	Completed
Phase	N/A
Start date	October 2013
Completion date	April 5, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05305001` - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Recruiting	`NCT04927780` - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer	Phase 3
Recruiting	`NCT06054984` - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT05919537` - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation	Phase 1
Terminated	`NCT03140670` - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy	Phase 2
Terminated	`NCT00529113` - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	Phase 1
Recruiting	`NCT05168527` - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05391126` - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care	N/A
Terminated	`NCT03300921` - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer	Phase 1
Completed	`NCT03153410` - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas	Early Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Recruiting	`NCT05679583` - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer	Phase 2
Recruiting	`NCT04183478` - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer	Phase 2/Phase 3
Terminated	`NCT03600623` - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT04584008` - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics	N/A
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Completed	`NCT04290364` - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study