Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

Gastric Cancer Clinical Trial

— SUPPORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04607057
• Other study ID #: H-2005-159-1126
• Status: Recruiting
• Phase: Phase 4
• Start date: December 22, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: Hyuk-Joon Lee, Professor
• Phone: 82-02-9092-3723
• Email: appe98[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who will undergo curative gastric cancer surgery (total gastrectomy, distal gastrectomy, proximal gastrectomy, and pylorus-preserving gastrectomy)

2. 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)

3. Patients over 18 years of age

4. Patients who are expected to receive PN for more than five days after surgery

5. Patients who are able to eat orally, but cannot fulfill the recommened calorie requirement by oral intake alone.

Exclusion Criteria:

1. 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)

2. In case that the patients need tube feeding

3. 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.

4. 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)

5. Vulnerable subject (those who lack the decision making ability, pregnant women, or women who are planning to conceive)

6. Other patients whom the investigator has determined to be inappropriate to participate in this study

Related Conditions & MeSH terms

• Gastrectomy
• Gastric Cancer
• Malnutrition
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of calorie provision during hospitalization	kcal (kilocalorie)	discharge day (POD#8; postoperative day 8)
Primary	Body weight change for 2 months after surgery	kg (kilogram)	Outpatient (visit 2: 2 months ± 14 days after surgery)
Secondary	Body weight and fat free mass changes	kg (kilogram)	Body weight: through study completion / Fat free mass: through study completion, an average of 1 year
Secondary	Changes in blood test indicators : Hb	Complete blood count : Hb (hemoglobin) : g/dl	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : WBC	Complete blood count : WBC (white blood cell) : cells/mm3	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : lymphocyte	Complete blood count : lymphocyte (%)	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : TLC	Complete blood count : TLC (total lymphocyte count) : cells/mm3	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : total cholesterol	Blood chemistry : total cholesterol (mg/dl)	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : total protein	Blood chemistry : total protein (g/dl)	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : albumin	Blood chemistry : albumin (g/dl)	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : AST	Blood chemistry : AST (aspartate aminotransferase) : IU/L	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : ALT	Blood chemistry : ALT (alanine aminotransferase) : IU/L	through study completion, an average of 1 year
Secondary	Changes in blood test indicators : CRP	Blood chemistry : CRP (C-reactive protein) : mg/dl	through study completion, an average of 1 year
Secondary	Changes in serum cytokines	ng/ml	approximately up to 2 weeks
Secondary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year
Secondary	QoL : SF-36	SF-36 (36-Item Short Form Health Survey) : 0~100 (higher scores mean a worse outcome)	through study completion, an average of 1 year
Secondary	Infection rate	proportion	During the hospitalization (approximately up to 2 weeks)
Secondary	Total days of hospitalization	day	at Discharge Day (POD#8; postoperative day 8)
Secondary	Mortality rate	proportion	through study completion, an average of 1 year