SUPPORT: Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04607057

Collaborator

(none)

224

Enrollment

Location

Arms

22.2

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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

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,

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Gastrectomy Malnutrition	Drug: Parenteral Nutrition Solutions	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

224 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Postoperative Supplemental Parenteral Nutrition (SPN) in Gastric Cancer Patients Who Underwent Gastrectomy: A Multicenter Prospective Randomized Controlled Trial

Actual Study Start Date :

Dec 22, 2020

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group (Arm A) 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	Drug: Parenteral Nutrition Solutions 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
No Intervention: control group (Arm B) 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)

Arm

Intervention/Treatment

Experimental: experimental group (Arm A)

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

Drug: Parenteral Nutrition Solutions

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

No Intervention: control group (Arm B)

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)

Outcome Measures

Primary Outcome Measures

Total amount of calorie provision during hospitalization [discharge day (POD#8; postoperative day 8)]
kcal (kilocalorie)
Body weight change for 2 months after surgery [Outpatient (visit 2: 2 months ± 14 days after surgery)]
kg (kilogram)

Secondary Outcome Measures

Body weight and fat free mass changes [Body weight: through study completion / Fat free mass: through study completion, an average of 1 year]
kg (kilogram)
Changes in blood test indicators : Hb [through study completion, an average of 1 year]
Complete blood count : Hb (hemoglobin) : g/dl
Changes in blood test indicators : WBC [through study completion, an average of 1 year]
Complete blood count : WBC (white blood cell) : cells/mm3
Changes in blood test indicators : lymphocyte [through study completion, an average of 1 year]
Complete blood count : lymphocyte (%)
Changes in blood test indicators : TLC [through study completion, an average of 1 year]
Complete blood count : TLC (total lymphocyte count) : cells/mm3
Changes in blood test indicators : total cholesterol [through study completion, an average of 1 year]
Blood chemistry : total cholesterol (mg/dl)
Changes in blood test indicators : total protein [through study completion, an average of 1 year]
Blood chemistry : total protein (g/dl)
Changes in blood test indicators : albumin [through study completion, an average of 1 year]
Blood chemistry : albumin (g/dl)
Changes in blood test indicators : AST [through study completion, an average of 1 year]
Blood chemistry : AST (aspartate aminotransferase) : IU/L
Changes in blood test indicators : ALT [through study completion, an average of 1 year]
Blood chemistry : ALT (alanine aminotransferase) : IU/L
Changes in blood test indicators : CRP [through study completion, an average of 1 year]
Blood chemistry : CRP (C-reactive protein) : mg/dl
Changes in serum cytokines [approximately up to 2 weeks]
ng/ml
Probability for chemotherapy : ECOG performance status [through study completion, an average of 1 year]
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 [through study completion, an average of 1 year]
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 [through study completion, an average of 1 year]
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 [through study completion, an average of 1 year]
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 [through study completion, an average of 1 year]
SF-36 (36-Item Short Form Health Survey) : 0~100 (higher scores mean a worse outcome)
Infection rate [During the hospitalization (approximately up to 2 weeks)]
proportion
Total days of hospitalization [at Discharge Day (POD#8; postoperative day 8)]
day
Mortality rate [through study completion, an average of 1 year]
proportion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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