Gastric CancerPhase 4SUPPORTNCT04607057

Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

A Phase 4 study testing Parenteral Nutrition Solutions in people with Gastric Cancer and Gastrectomy, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric Cancer, Gastrectomy, Malnutrition
What is being tested?: Parenteral Nutrition Solutions
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 1 siteSouth Korea
Study dates: 22 Dec 2020to 30 Oct 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hyuk-Joon Lee, Professor contact

82-02-9092-3723

appe98@snu.ac.kr

Sa-Hong Kim, Fellow contact

82-10-7588-5477

kshsnuhgs@gmail.com

South Korea1 site, 1 recruiting

Seoul National University Hospital
Seoul
Hyuk-Joon Lee, MD, PhD, appe98@snu.ac.kr
Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Conditions: Gastric Cancer, Gastrectomy, Malnutrition
Being tested: Parenteral Nutrition Solutions
Keywords: Gastric cancer, Postgastrectomy, Malnutrition, Supplemental, Parenteral nutrition
Medical subject headings: Stomach Neoplasms, Malnutrition, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Parenteral Nutrition SolutionsDrug
- 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

Study groups in NCT04607057
Study group	Role	What they receive
experimental group (Arm A)	Experimental	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 Receives: Drug: Parenteral Nutrition Solutions
control group (Arm B)	No intervention	* 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (20)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 202030 Oct 2022

First posted28 Oct 2020
Study start22 Dec 2020
Primary completion30 Oct 2022 (estimated)
Study completion30 Oct 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 224 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04607057
Sponsor's protocol ID: H-2005-159-1126
Acronym: SUPPORT
Status last verified: Sep 2021
First submitted: 12 Oct 2020
Last updated: 24 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Sharing the specific individual participant data sets is not mandatory.

Publications

Scholmerich J. Postgastrectomy syndromes--diagnosis and treatment. Best Pract Res Clin Gastroenterol. 2004 Oct;18(5):917-33. doi: 10.1016/j.bpg.2004.08.003.
PubMed 15494286
Pedrazzani C, Marrelli D, Rampone B, De Stefano A, Corso G, Fotia G, Pinto E, Roviello F. Postoperative complications and functional results after subtotal gastrectomy with Billroth II reconstruction for primary gastric cancer. Dig Dis Sci. 2007 Aug;52(8):1757-63. doi: 10.1007/s10620-006-9655-6. Epub 2007 Apr 3.
PubMed 17404848
Jee SH, Sull JW, Park J, Lee SY, Ohrr H, Guallar E, Samet JM. Body-mass index and mortality in Korean men and women. N Engl J Med. 2006 Aug 24;355(8):779-87. doi: 10.1056/NEJMoa054017. Epub 2006 Aug 22.
PubMed 16926276
Migita K, Takayama T, Saeki K, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Kurumatani N, Nakajima Y. The prognostic nutritional index predicts long-term outcomes of gastric cancer patients independent of tumor stage. Ann Surg Oncol. 2013 Aug;20(8):2647-54. doi: 10.1245/s10434-013-2926-5. Epub 2013 Mar 6.
PubMed 23463091
Aoyama T, Yoshikawa T, Shirai J, Hayashi T, Yamada T, Tsuchida K, Hasegawa S, Cho H, Yukawa N, Oshima T, Rino Y, Masuda M, Tsuburaya A. Body weight loss after surgery is an independent risk factor for continuation of S-1 adjuvant chemotherapy for gastric cancer. Ann Surg Oncol. 2013 Jun;20(6):2000-6. doi: 10.1245/s10434-012-2776-6. Epub 2012 Dec 16.
PubMed 23242818
Aoyama T, Sato T, Maezawa Y, Kano K, Hayashi T, Yamada T, Yukawa N, Oshima T, Rino Y, Masuda M, Ogata T, Cho H, Yoshikawa T. Postoperative weight loss leads to poor survival through poor S-1 efficacy in patients with stage II/III gastric cancer. Int J Clin Oncol. 2017 Jun;22(3):476-483. doi: 10.1007/s10147-017-1089-y. Epub 2017 Feb 7.
PubMed 28176023
Beattie AH, Prach AT, Baxter JP, Pennington CR. A randomised controlled trial evaluating the use of enteral nutritional supplements postoperatively in malnourished surgical patients. Gut. 2000 Jun;46(6):813-8. doi: 10.1136/gut.46.6.813.
PubMed 10807893
Smedley F, Bowling T, James M, Stokes E, Goodger C, O'Connor O, Oldale C, Jones P, Silk D. Randomized clinical trial of the effects of preoperative and postoperative oral nutritional supplements on clinical course and cost of care. Br J Surg. 2004 Aug;91(8):983-90. doi: 10.1002/bjs.4578.
PubMed 15286958
Kong SH, Lee HJ, Na JR, Kim WG, Han DS, Park SH, Hong H, Choi Y, Ahn HS, Suh YS, Yang HK. Effect of perioperative oral nutritional supplementation in malnourished patients who undergo gastrectomy: A prospective randomized trial. Surgery. 2018 Dec;164(6):1263-1270. doi: 10.1016/j.surg.2018.05.017. Epub 2018 Jul 25.
PubMed 30055788
Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.
PubMed 25271389
Kong SH, Park JS, Lee IK, Ryu SW, Park YK, Yang HK, Han SU, Yoon KY, Jeong SY, Jeong MR, Hwang DW, Suh YS, Yoon YS, Seo KW, Park JW, Byun CS, Hur H, Won H, Choi Y, Lee HJ. Postoperative oral nutritional supplementation after major gastrointestinal surgery: a randomized controlled clinical trial. Asia Pac J Clin Nutr. 2017;26(5):811-819. doi: 10.6133/apjcn.112016.02.
PubMed 28802290
Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
PubMed 12765673
Kobayashi D, Ishigure K, Mochizuki Y, Nakayama H, Sakai M, Ito S, Kojima H, Kajikawa M, Ando M, Kodera Y. Multi-institutional prospective feasibility study to explore tolerability and efficacy of oral nutritional supplements for patients with gastric cancer undergoing gastrectomy (CCOG1301). Gastric Cancer. 2017 Jul;20(4):718-727. doi: 10.1007/s10120-016-0668-3. Epub 2016 Nov 24.
PubMed 27885538
Russell MK, Wischmeyer PE. Supplemental Parenteral Nutrition: Review of the Literature and Current Nutrition Guidelines. Nutr Clin Pract. 2018 Jun;33(3):359-369. doi: 10.1002/ncp.10096.
PubMed 29878557
Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.
PubMed 19851094

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Postoperative Supplemental Parenteral Nutrition (SPN) in Gastric Cancer Patients Who Underwent Gastrectomy: A Multicenter Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04607057
Acronym / sponsor ID: SUPPORT / H-2005-159-1126
Conditions: Gastric Cancer, Gastrectomy, Malnutrition
Keywords: Gastric cancer, Postgastrectomy, Malnutrition, Supplemental, Parenteral nutrition
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 224 participants (estimated)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: 22 Dec 2020 (actual)
Primary completion: 30 Oct 2022 (estimated)
Study completion: 30 Oct 2022 (estimated)
First posted: 28 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group (Arm A)	Experimental	Drug: Parenteral Nutrition SolutionsPreparation 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
control group (Arm B)	No intervention	–* 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:
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.

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Drug	experimental group (Arm A)

Primary outcome

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

20 secondary outcomes

Body weight and fat free mass changes
Time frame: Body weight: through study completion / Fat free mass: through study completion, an average of 1 year
Changes in blood test indicators : Hb
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : WBC
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : lymphocyte
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : TLC
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : total cholesterol
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : total protein
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : albumin
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : AST
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : ALT
Time frame: through study completion, an average of 1 year
Changes in blood test indicators : CRP
Time frame: through study completion, an average of 1 year
Changes in serum cytokines
Time frame: approximately up to 2 weeks
Probability for chemotherapy : ECOG performance status
Time frame: through study completion, an average of 1 year
Probability for chemotherapy : ASA score
Time frame: through study completion, an average of 1 year
QoL : EORTC QLQ-C30
Time frame: through study completion, an average of 1 year
QoL : EORTC QLQ-STO22
Time frame: through study completion, an average of 1 year
QoL : SF-36
Time frame: through study completion, an average of 1 year
Infection rate
Time frame: During the hospitalization (approximately up to 2 weeks)
Total days of hospitalization
Time frame: at Discharge Day (POD#8; postoperative day 8)
Mortality rate
Time frame: through study completion, an average of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
Background: PubMed 15494286Scholmerich J. Postgastrectomy syndromes--diagnosis and treatment. Best Pract Res Clin Gastroenterol. 2004 Oct;18(5):917-33. doi: 10.1016/j.bpg.2004.08.003.
Background: PubMed 17404848Pedrazzani C, Marrelli D, Rampone B, De Stefano A, Corso G, Fotia G, Pinto E, Roviello F. Postoperative complications and functional results after subtotal gastrectomy with Billroth II reconstruction for primary gastric cancer. Dig Dis Sci. 2007 Aug;52(8):1757-63. doi: 10.1007/s10620-006-9655-6. Epub 2007 Apr 3.
Background: PubMed 16926276Jee SH, Sull JW, Park J, Lee SY, Ohrr H, Guallar E, Samet JM. Body-mass index and mortality in Korean men and women. N Engl J Med. 2006 Aug 24;355(8):779-87. doi: 10.1056/NEJMoa054017. Epub 2006 Aug 22.
Background: PubMed 23463091Migita K, Takayama T, Saeki K, Matsumoto S, Wakatsuki K, Enomoto K, Tanaka T, Ito M, Kurumatani N, Nakajima Y. The prognostic nutritional index predicts long-term outcomes of gastric cancer patients independent of tumor stage. Ann Surg Oncol. 2013 Aug;20(8):2647-54. doi: 10.1245/s10434-013-2926-5. Epub 2013 Mar 6.
Background: PubMed 23242818Aoyama T, Yoshikawa T, Shirai J, Hayashi T, Yamada T, Tsuchida K, Hasegawa S, Cho H, Yukawa N, Oshima T, Rino Y, Masuda M, Tsuburaya A. Body weight loss after surgery is an independent risk factor for continuation of S-1 adjuvant chemotherapy for gastric cancer. Ann Surg Oncol. 2013 Jun;20(6):2000-6. doi: 10.1245/s10434-012-2776-6. Epub 2012 Dec 16.
Background: PubMed 28176023Aoyama T, Sato T, Maezawa Y, Kano K, Hayashi T, Yamada T, Yukawa N, Oshima T, Rino Y, Masuda M, Ogata T, Cho H, Yoshikawa T. Postoperative weight loss leads to poor survival through poor S-1 efficacy in patients with stage II/III gastric cancer. Int J Clin Oncol. 2017 Jun;22(3):476-483. doi: 10.1007/s10147-017-1089-y. Epub 2017 Feb 7.
Background: PubMed 10807893Beattie AH, Prach AT, Baxter JP, Pennington CR. A randomised controlled trial evaluating the use of enteral nutritional supplements postoperatively in malnourished surgical patients. Gut. 2000 Jun;46(6):813-8. doi: 10.1136/gut.46.6.813.
Background: PubMed 15286958Smedley F, Bowling T, James M, Stokes E, Goodger C, O'Connor O, Oldale C, Jones P, Silk D. Randomized clinical trial of the effects of preoperative and postoperative oral nutritional supplements on clinical course and cost of care. Br J Surg. 2004 Aug;91(8):983-90. doi: 10.1002/bjs.4578.
Background: PubMed 30055788Kong SH, Lee HJ, Na JR, Kim WG, Han DS, Park SH, Hong H, Choi Y, Ahn HS, Suh YS, Yang HK. Effect of perioperative oral nutritional supplementation in malnourished patients who undergo gastrectomy: A prospective randomized trial. Surgery. 2018 Dec;164(6):1263-1270. doi: 10.1016/j.surg.2018.05.017. Epub 2018 Jul 25.
Background: PubMed 25271389Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.
Background: PubMed 28802290Kong SH, Park JS, Lee IK, Ryu SW, Park YK, Yang HK, Han SU, Yoon KY, Jeong SY, Jeong MR, Hwang DW, Suh YS, Yoon YS, Seo KW, Park JW, Byun CS, Hur H, Won H, Choi Y, Lee HJ. Postoperative oral nutritional supplementation after major gastrointestinal surgery: a randomized controlled clinical trial. Asia Pac J Clin Nutr. 2017;26(5):811-819. doi: 10.6133/apjcn.112016.02.
Background: PubMed 12765673Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
Individual participant dataSharing planned: No. Sharing the specific individual participant data sets is not mandatory.

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Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyuk-Joon Lee, Professor contact

82-02-9092-3723

appe98@snu.ac.kr

Sa-Hong Kim, Fellow contact

82-10-7588-5477

kshsnuhgs@gmail.com

Hyuk-Joon Lee, Professor principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Parenteral Nutrition Solutions in people with Gastric Cancer and Gastrectomy, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyuk-Joon Lee, Professor (82-02-9092-3723, appe98@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total amount of calorie provision during hospitalization (time frame: discharge day (POD#8; postoperative day 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607057, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.