Back to resultsSupplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient (SUPPORT)
Primary Purpose
Gastric Cancer, Gastrectomy, Malnutrition
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Parenteral Nutrition Solutions
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Postgastrectomy, Malnutrition, Supplemental, Parenteral nutrition
Eligibility Criteria
Inclusion Criteria:
- Patients who will undergo curative gastric cancer surgery (total gastrectomy, distal gastrectomy, proximal gastrectomy, and pylorus-preserving gastrectomy)
A Malnourished patient who meets one or more of the following:
- BMI ≤ 20.5 kg/m2: BMI will be measured 1 day before surgery
- Rapid weight loss (decreased by more than 5% in 2 months)
- Patients over 18 years of age
- Patients who are expected to receive PN for more than five days after surgery
- Patients who are able to eat orally, but cannot fulfill the recommened calorie requirement by oral intake alone.
Exclusion Criteria:
- In case that the patients have already provided parenteral nutrition prior to the consent of the study (oral diet prior to consent has nothing to do with study)
- In case that the patients need tube feeding
- Patients who are contraindicated to parenteral nutrition: heart failure (if the patient has current symptoms or receiving heart failure treatment, if ejection fraction(EF) was less than 40% in preoperative echocardiogram), Child-Pugh score C, renal failure (patient with 50% increased creatinine more than upper normal limit, patients currently undergoing renal replacement therapy), and pulmonary edema (appropriate chest X-ray signs for pulmonary edema), and the patient who suffered from allergie reaction to parenteral nutrition solutions.
- Patients who are not easily able to obtain venous pathways or are vulnerable to side effects due to venous pathways (e.g. increased infection risk due to immunosupressant status)
- Vulnerable subject (those who lack the decision making ability, pregnant women, or women who are planning to conceive)
- Other patients whom the investigator has determined to be inappropriate to participate in this study
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group (Arm A)
control group (Arm B)
Arm Description
Preparation of parenteral nutrition (PN): Among winuf(1820cc for central vein, 1,450cc for peripheral vein), smofkabaven(986cc for central vein, 1206cc for peripheral vein), and nutriplex(1875cc for central vein, 1,250cc for peripheral vein) Amount of PN: Total energy expenditure (TEE) of the patients will be calculated with Harris-Benedict Equation, activity factor, and stress factor. The amount of calorie from oral intake will be subtracted from TEE then the remainder will be provided through PN. Route of PN Injection: PICC (percutaneously-inserted central catheter) will be secured for PN for the central vein. PN for the peripheral vein will be injected directly through peripheral superficial vein. Day0 : fasting(NPO) + crystalloid fluid POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid POD#2 : Semifluid diet (SFD) + crystalloid fluid POD#3 : Semifluid diet (SFD) + PN POD#4-7: Soft blended diet (SBD) + PN
Day0 : fasting(NPO) + crystalloid fluid POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid POD#2 : Semifluid diet (SFD) + dextrose 5% water POD#3 : Semifluid diet (SFD) + dextrose 5% water POD#4-7: Soft blended diet (SBD)
Outcomes
Primary Outcome Measures
Total amount of calorie provision during hospitalization
kcal (kilocalorie)
Body weight change for 2 months after surgery
kg (kilogram)
Secondary Outcome Measures
Body weight and fat free mass changes
kg (kilogram)
Changes in blood test indicators : Hb
Complete blood count : Hb (hemoglobin) : g/dl
Changes in blood test indicators : WBC
Complete blood count : WBC (white blood cell) : cells/mm3
Changes in blood test indicators : lymphocyte
Complete blood count : lymphocyte (%)
Changes in blood test indicators : TLC
Complete blood count : TLC (total lymphocyte count) : cells/mm3
Changes in blood test indicators : total cholesterol
Blood chemistry : total cholesterol (mg/dl)
Changes in blood test indicators : total protein
Blood chemistry : total protein (g/dl)
Changes in blood test indicators : albumin
Blood chemistry : albumin (g/dl)
Changes in blood test indicators : AST
Blood chemistry : AST (aspartate aminotransferase) : IU/L
Changes in blood test indicators : ALT
Blood chemistry : ALT (alanine aminotransferase) : IU/L
Changes in blood test indicators : CRP
Blood chemistry : CRP (C-reactive protein) : mg/dl
Changes in serum cytokines
ng/ml
Probability for chemotherapy : ECOG performance status
ECOG(Eastern Cooperative Oncology Group) performance status: 0~5 (higher scores mean a worse outcome) 0 : Fully active, able to carry on all pre-disease performance without restriction 5 : Death
Probability for chemotherapy : ASA score
ASA(American Society of Anaesthesiologists) score : 1~6 (higher scores mean a worse outcome)
1 : A normal healthy patient 6 : A declared brain-dead patient whose organs are being removed for donor purposes
QoL : EORTC QLQ-C30
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) : EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001).
QoL : EORTC QLQ-STO22
EORTC QLQ-STO22 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach 22) : Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer (J.M Blazeby el al. 2004).
QoL : SF-36
SF-36 (36-Item Short Form Health Survey) : 0~100 (higher scores mean a worse outcome)
Infection rate
proportion
Total days of hospitalization
day
Mortality rate
proportion
Full Information
NCT ID
NCT04607057
First Posted
October 12, 2020
Last Updated
September 22, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04607057
Brief Title
Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient
Acronym
SUPPORT
Official Title
The Effect of Postoperative Supplemental Parenteral Nutrition (SPN) in Gastric Cancer Patients Who Underwent Gastrectomy: A Multicenter Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
If a patient undergoes gastrectomy, which is a kind of major abdominal operation, he/she loses more than 5% of his/her body weight in 2 months after surgery. This point is one of the criteria of 'risk of malnutrition' according to Nutrition Risk Screening (NRS 2002) and the patient who corresponds to this criterion needs nutritional support.
According to Nutrition Risk Screening (NRS 2002), moderate malnutrition is defined as the state that the patient orally intakes 25~50% of recommended requirements; severe malnutrition is less than 25%.
Meanwhile, when oral nutrition support was provided to patients after gastric cancer surgery, the patients' average daily intake during the first three months was about a half of the recommended requirements.
Putting together the facts i) that the patient underwent major abdominal operation, ii) that the weight loss rate exceeded 5% for two months, iii) that the average daily intake of patients during the first three months was about half of the recommended amount, the patients are eligible to be classified as a group who require nutritional support according to NRS 2002.
Therefore, it is intended to verify the efficacy and safety of supplemental parenteral nutrition by comparing Arm A, who are provided oral intake with supplemental parenteral nutrition, Arm B, who are provided oral intake only after curative gastric cancer surgery.
Detailed Description
With at least 5 days of supplemental parenteral nutrition, we expect minimized body weight loss, favorable blood test result, eligibility for chemotherapy compliance, increased quality of life (QoL), decreased infection rate, decreased hospital stay, and decreased mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastrectomy, Malnutrition
Keywords
Gastric cancer, Postgastrectomy, Malnutrition, Supplemental, Parenteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group (Arm A)
Arm Type
Experimental
Arm Description
Preparation of parenteral nutrition (PN): Among winuf(1820cc for central vein, 1,450cc for peripheral vein), smofkabaven(986cc for central vein, 1206cc for peripheral vein), and nutriplex(1875cc for central vein, 1,250cc for peripheral vein) Amount of PN: Total energy expenditure (TEE) of the patients will be calculated with Harris-Benedict Equation, activity factor, and stress factor. The amount of calorie from oral intake will be subtracted from TEE then the remainder will be provided through PN.
Route of PN Injection: PICC (percutaneously-inserted central catheter) will be secured for PN for the central vein. PN for the peripheral vein will be injected directly through peripheral superficial vein.
Day0 : fasting(NPO) + crystalloid fluid
POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
POD#2 : Semifluid diet (SFD) + crystalloid fluid
POD#3 : Semifluid diet (SFD) + PN
POD#4-7: Soft blended diet (SBD) + PN
Arm Title
control group (Arm B)
Arm Type
No Intervention
Arm Description
Day0 : fasting(NPO) + crystalloid fluid
POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
POD#2 : Semifluid diet (SFD) + dextrose 5% water
POD#3 : Semifluid diet (SFD) + dextrose 5% water
POD#4-7: Soft blended diet (SBD)
Intervention Type
Drug
Intervention Name(s)
Parenteral Nutrition Solutions
Intervention Description
Day0 : fasting(NPO) + crystalloid fluid
POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
POD#2 : Semifluid diet (SFD) + crystalloid fluid
POD#3 : Semifluid diet (SFD) + PN
POD#4-7: Soft blended diet (SBD) + PN
Primary Outcome Measure Information:
Title
Total amount of calorie provision during hospitalization
Description
kcal (kilocalorie)
Time Frame
discharge day (POD#8; postoperative day 8)
Title
Body weight change for 2 months after surgery
Description
kg (kilogram)
Time Frame
Outpatient (visit 2: 2 months ± 14 days after surgery)
Secondary Outcome Measure Information:
Title
Body weight and fat free mass changes
Description
kg (kilogram)
Time Frame
Body weight: through study completion / Fat free mass: through study completion, an average of 1 year
Title
Changes in blood test indicators : Hb
Description
Complete blood count : Hb (hemoglobin) : g/dl
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : WBC
Description
Complete blood count : WBC (white blood cell) : cells/mm3
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : lymphocyte
Description
Complete blood count : lymphocyte (%)
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : TLC
Description
Complete blood count : TLC (total lymphocyte count) : cells/mm3
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : total cholesterol
Description
Blood chemistry : total cholesterol (mg/dl)
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : total protein
Description
Blood chemistry : total protein (g/dl)
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : albumin
Description
Blood chemistry : albumin (g/dl)
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : AST
Description
Blood chemistry : AST (aspartate aminotransferase) : IU/L
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : ALT
Description
Blood chemistry : ALT (alanine aminotransferase) : IU/L
Time Frame
through study completion, an average of 1 year
Title
Changes in blood test indicators : CRP
Description
Blood chemistry : CRP (C-reactive protein) : mg/dl
Time Frame
through study completion, an average of 1 year
Title
Changes in serum cytokines
Description
ng/ml
Time Frame
approximately up to 2 weeks
Title
Probability for chemotherapy : ECOG performance status
Description
ECOG(Eastern Cooperative Oncology Group) performance status: 0~5 (higher scores mean a worse outcome) 0 : Fully active, able to carry on all pre-disease performance without restriction 5 : Death
Time Frame
through study completion, an average of 1 year
Title
Probability for chemotherapy : ASA score
Description
ASA(American Society of Anaesthesiologists) score : 1~6 (higher scores mean a worse outcome)
1 : A normal healthy patient 6 : A declared brain-dead patient whose organs are being removed for donor purposes
Time Frame
through study completion, an average of 1 year
Title
QoL : EORTC QLQ-C30
Description
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) : EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001).
Time Frame
through study completion, an average of 1 year
Title
QoL : EORTC QLQ-STO22
Description
EORTC QLQ-STO22 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Stomach 22) : Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer (J.M Blazeby el al. 2004).
Time Frame
through study completion, an average of 1 year
Title
QoL : SF-36
Description
SF-36 (36-Item Short Form Health Survey) : 0~100 (higher scores mean a worse outcome)
Time Frame
through study completion, an average of 1 year
Title
Infection rate
Description
proportion
Time Frame
During the hospitalization (approximately up to 2 weeks)
Title
Total days of hospitalization
Description
day
Time Frame
at Discharge Day (POD#8; postoperative day 8)
Title
Mortality rate
Description
proportion
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who will undergo curative gastric cancer surgery (total gastrectomy, distal gastrectomy, proximal gastrectomy, and pylorus-preserving gastrectomy)
A Malnourished patient who meets one or more of the following:
BMI ≤ 20.5 kg/m2: BMI will be measured 1 day before surgery
Rapid weight loss (decreased by more than 5% in 2 months)
Patients over 18 years of age
Patients who are expected to receive PN for more than five days after surgery
Patients who are able to eat orally, but cannot fulfill the recommened calorie requirement by oral intake alone.
Exclusion Criteria:
In case that the patients have already provided parenteral nutrition prior to the consent of the study (oral diet prior to consent has nothing to do with study)
In case that the patients need tube feeding
Patients who are contraindicated to parenteral nutrition: heart failure (if the patient has current symptoms or receiving heart failure treatment, if ejection fraction(EF) was less than 40% in preoperative echocardiogram), Child-Pugh score C, renal failure (patient with 50% increased creatinine more than upper normal limit, patients currently undergoing renal replacement therapy), and pulmonary edema (appropriate chest X-ray signs for pulmonary edema), and the patient who suffered from allergie reaction to parenteral nutrition solutions.
Patients who are not easily able to obtain venous pathways or are vulnerable to side effects due to venous pathways (e.g. increased infection risk due to immunosupressant status)
Vulnerable subject (those who lack the decision making ability, pregnant women, or women who are planning to conceive)
Other patients whom the investigator has determined to be inappropriate to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyuk-Joon Lee, Professor
Phone
82-02-9092-3723
Email
appe98@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sa-Hong Kim, Fellow
Phone
82-10-7588-5477
Email
kshsnuhgs@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuk-Joon Lee, MD, PhD
Email
appe98@snu.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Sharing the specific individual participant data sets is not mandatory.
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Lee JH, Lee HJ, Choi YS, Kim TH, Huh YJ, Suh YS, Kong SH, Yang HK. Postoperative Quality of Life after Total Gastrectomy Compared with Partial Gastrectomy: Longitudinal Evaluation by European Organization for Research and Treatment of Cancer-OG25 and STO22. J Gastric Cancer. 2016 Dec;16(4):230-239. doi: 10.5230/jgc.2016.16.4.230. Epub 2016 Dec 20.
Results Reference
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PubMed Identifier
10022643
Citation
Svedlund J, Sullivan M, Liedman B, Lundell L. Long term consequences of gastrectomy for patient's quality of life: the impact of reconstructive techniques. Am J Gastroenterol. 1999 Feb;94(2):438-45. doi: 10.1111/j.1572-0241.1999.874_c.x.
Results Reference
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Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient
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