Gastric CancerSINGNCT04798820
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
A study testing Dietary education(nutritional counselling) in people with Gastric Cancer and Gastrectomy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastrectomy
- What is being tested?
- Dietary education(nutritional counselling)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2021to Oct 2025
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven primary gastric adenocarcinoma,
- T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
- location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
- No evidence of other distant metastasis,
- age ≥ 20 year old, ≤ 75 year old
- no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies
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- adequate organ functions defined as indicated below:
- WBC count: 3000/mm3 ~12,000/mm3,
- > serum Hemoglobin 8.0 g/dL
- > serum Platelet 100 000/mm3,
- < serum AST 100 IU/L,
- <serum ALT 100 IU/L,
- < Total Bilirubin 2.0 mg/dL,
- written signed informed consent
Who cannot join
- active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer),
- gastric remnant cancer
- ≥T3, T4 in surgical staging before resection
- N2 or more (number of metastatic lymph nodes ≥3) in CT scan
- histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others
- pregnant or breast-feeding women,
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- mental disorder(diagnosed with mental disorder on medical record),
- unstable angina or myocardial infarction within 6 months of the trial,
- unstable hypertension,
- diabetes mellitus on insulin,
- severe respiratory disease requiring continuous oxygen therapy,
- previous upper abdominal surgery except laparoscopic cholecystectomy,
- surgical complication
Trial locations and contacts
1 site in 1 country.
Aron Lee, RD contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung medical center
Seoul, 06351
Aron Lee, 82-2-2148-9802
About this study
Official title: A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.
Read the detailed description
Subject 1: subtotal gastrectomy group
subject 2: total gastrectomy group
Objectives:
Primary objective: to evaluate Weight loss difference of simplified dietary education(SE) versus intensive dietary education(IE) for patients after undergoing a gastrectomy
Primary endpoint: Superiority of weight loss difference (%) of IE group between post op 1mo and 12mo
Secondary objectives:
weight loss(%) of each subgroup, nutritional parameters (PG-SGA), Calrorie intake \& dietary habits, albumin, hemoglobin, iron panel (TIBC, ferritin), Absolute lymphocyte count(ALC), vit B12, homocysteine, quality of life(QOL) change
- Nutritional parameters (PG-SGA)
- the amount of calorie intake (Kcal, protein) \& dietary habits
- Albumin (g/dL)
- Hemoglobin (g/dL)
- Iron panel [TIBC (μg/dL), Ferritin (ng/mL)]
- Absolute lymphocyte count (ALC) (10^3/μL)
- Vitamin B12 (pg/mL)
- Homocysteine (μmol/L)
- Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
- Conditions
- Gastric Cancer, Gastrectomy
- Being tested
- Dietary education(nutritional counselling)
- Keywords
- gastric cancer, gastrectomy, dietary education, nutritional status
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary education(nutritional counselling)Other
Dietary education provided to gastrectomy patients by dietitian.
| Study group | Role | What they receive |
|---|---|---|
| SE-STG | Active comparator | simplified dietary education arm in subtotal gastrectomy group. Receives: Other: Dietary education(nutritional counselling) |
| IE-STG | Active comparator | intensive dietary education arm in subtotal gastrectomy group Receives: Other: Dietary education(nutritional counselling) |
| SE-TG | Active comparator | simplified dietary education arm in total gastrectomy group. Receives: Other: Dietary education(nutritional counselling) |
| IE-TG | Active comparator | intensive dietary education arm in total gastrectomy group Receives: Other: Dietary education(nutritional counselling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative weight change at immediate postoperative period in SE and IE groups.
comparison of weight change between the two groups after surgery
Measured: preoperative, immediate postoperative
Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
comparison of weight change between the two groups after surgery
Measured: preoperative, postoperative 1 month
Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Measured: preoperative, postoperative 3 months
Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Measured: preoperative, postoperative 6 months
Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Measured: preoperative, postoperative 12 months
Change from preoperative weight change at postoperaive 18 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Measured: preoperative, postoperative 18 months
Secondary outcomes (11)
Nutritional parameters
measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
24hrs dietary recall
calculating kcal \& protein intake by 24hrs dietary recall (questionnaire)
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
dietary habits
number of meals, eating speed (questionnaire)
Measured: preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months
Albumin
g/dL
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Hemoglobin
g/dL
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Total iron binding capacity (TIBC)
μg/dL
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Ferritin
ng/mL
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Absolute lymphocyte count (ALC)
10^3/μL
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Vitamin B12
pg/mL
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Homocysteine
μmol/L
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Quality of life of the patients
European quality of life questionnaire (EQ-5D); the descriptive system which comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3).
Measured: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start9 Mar 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Samsung Medical CenterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simplified dietary education(SE) versus Intensive dietary education(IE) 1. Subtotal gastrectomy group (n=258) 2. Total gastrectomy group (n=100)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Moon Bae, Samsung Medical Center
- Investigators
- Aron Lee, RD, Study director, Samsung Medical CenterBo Ram Park, Ph.D., Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798820
- Sponsor's protocol ID
- SMC 2020-11-016-002
- Acronym
- SING
- Status last verified
- Jul 2024
- First submitted
- 5 Mar 2021
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee AR, Bae JM, Choi MG, An JY, Kim EM, Park B. Nutritional Counseling for Patients With Gastric Cancer After Subtotal Gastrectomy: A Randomized Clinical Trial. J Gastric Cancer. 2025 Oct;25(4):593-604. doi: 10.5230/jgc.2025.25.e43.
PubMed 41093778
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
- ClinicalTrials.gov ID
- NCT04798820
- Acronym / sponsor ID
- SING / SMC 2020-11-016-002
- Conditions
- Gastric Cancer, Gastrectomy
- Keywords
- gastric cancer, gastrectomy, dietary education, nutritional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Mar 2021 (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.
Radical gastrectomy has been known as the most effective treatment of curable gastric cancer.However, there is a high risk of malnutrition and weight loss after a gastrectomy which may be attributed to inadequate oral consumption, malabsorption and loss of the reservoir function of the stomach.Weight loss has been regarded as an independent risk factor for postoperative mortality and morbidity and It is also closely associated with a quality of life after surgery. No specific surgical technique has been proved to be effective in reducing postoperative weight loss and it seems like that dietary education and consultation is the best way to minimize weight loss in gastrectomy patients in clinical setting. In this regard, the investigators performed a retrospective pilot study to identify the effect of routinely performed (simplified) dietary education on nutritional status after gastrectomy, but it revealed that the effect of simplified dietary education on weight loss was not clear and the result implies that more intensive dietary education may be necessary after gastrectomy. The aim of this randomized controlled trial (RCT) is to elucidate the effect of intensive dietary education on nutritional status after gastrectomy in comparison with simplified dietary education.
Detailed description
Subject 1: subtotal gastrectomy group
subject 2: total gastrectomy group
Objectives:
Primary objective: to evaluate Weight loss difference of simplified dietary education(SE) versus intensive dietary education(IE) for patients after undergoing a gastrectomy
Primary endpoint: Superiority of weight loss difference (%) of IE group between post op 1mo and 12mo
Secondary objectives:
weight loss(%) of each subgroup, nutritional parameters (PG-SGA), Calrorie intake \& dietary habits, albumin, hemoglobin, iron panel (TIBC, ferritin), Absolute lymphocyte count(ALC), vit B12, homocysteine, quality of life(QOL) change
- Nutritional parameters (PG-SGA)
- the amount of calorie intake (Kcal, protein) \& dietary habits
- Albumin (g/dL)
- Hemoglobin (g/dL)
- Iron panel [TIBC (μg/dL), Ferritin (ng/mL)]
- Absolute lymphocyte count (ALC) (10^3/μL)
- Vitamin B12 (pg/mL)
- Homocysteine (μmol/L)
- Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Simplified dietary education(SE) versus Intensive dietary education(IE) 1. Subtotal gastrectomy group (n=258) 2. Total gastrectomy group (n=100)
| Arm | Type | Receives |
|---|---|---|
| SE-STG | Active comparator | Other: Dietary education(nutritional counselling)simplified dietary education arm in subtotal gastrectomy group. |
| IE-STG | Active comparator | Other: Dietary education(nutritional counselling)intensive dietary education arm in subtotal gastrectomy group |
| SE-TG | Active comparator | Other: Dietary education(nutritional counselling)simplified dietary education arm in total gastrectomy group. |
| IE-TG | Active comparator | Other: Dietary education(nutritional counselling)intensive dietary education arm in total gastrectomy group |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- histologically proven primary gastric adenocarcinoma,
- T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
- location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
- No evidence of other distant metastasis,
- age ≥ 20 year old, ≤ 75 year old
Key exclusion criteria (13 listed)
- active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer),
- gastric remnant cancer
- ≥T3, T4 in surgical staging before resection
- N2 or more (number of metastatic lymph nodes ≥3) in CT scan
- histologically rare variants in World Health Organization (WHO) Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, neuroendocrine carcinoma and others
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 |
|---|---|---|
| Dietary education(nutritional counselling)Dietary education provided to gastrectomy patients by dietitian. | Other | IE-STG, IE-TG, SE-STG, SE-TG |
Primary outcome
Change from preoperative weight change at immediate postoperative period in SE and IE groups.
Time frame: preoperative, immediate postoperative
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
Time frame: preoperative, postoperative 1 month
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
Time frame: preoperative, postoperative 3 months
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
Time frame: preoperative, postoperative 6 months
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
Time frame: preoperative, postoperative 12 months
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 18 months in SE and IE groups.
Time frame: preoperative, postoperative 18 months
comparison of weight change between the two groups after surgery
11 secondary outcomes
Nutritional parameters
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
24hrs dietary recall
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
dietary habits
Time frame: preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months
Albumin
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Hemoglobin
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Total iron binding capacity (TIBC)
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Ferritin
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Absolute lymphocyte count (ALC)
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Vitamin B12
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Homocysteine
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Quality of life of the patients
Time frame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 41093778Lee AR, Bae JM, Choi MG, An JY, Kim EM, Park B. Nutritional Counseling for Patients With Gastric Cancer After Subtotal Gastrectomy: A Randomized Clinical Trial. J Gastric Cancer. 2025 Oct;25(4):593-604. doi: 10.5230/jgc.2025.25.e43.
- Individual participant dataSharing planned: No
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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.
Aron Lee, RD contact
Aron Lee, RD study director
Samsung Medical Center
Bo Ram Park, Ph.D. study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary education(nutritional counselling) in people with Gastric Cancer and Gastrectomy, run by Samsung Medical Center 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 14 inclusion and 13 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 15 Jul 2024. 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.
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 Jae-Moon Bae, MD, Ph.D (82-2-3410-0252, jmoon.bae@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from preoperative weight change at immediate postoperative period in SE and IE groups. (time frame: preoperative, immediate postoperative). The study lists 6 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 NCT04798820, which also lists 1 linked publication.
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 15 Jul 2024.