The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)

NCT ID: NCT04798820

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2025-10-31

Brief 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 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

1. Nutritional parameters (PG-SGA)

2. the amount of calorie intake (Kcal, protein) & dietary habits

3. Albumin (g/dL)

4. Hemoglobin (g/dL)

5. Iron panel [TIBC (μg/dL), Ferritin (ng/mL)]

6. Absolute lymphocyte count (ALC) (10^3/μL)

7. Vitamin B12 (pg/mL)

8. Homocysteine (μmol/L)

9. Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)

Conditions

Gastric Cancer; Gastrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

SE-STG

simplified dietary education arm in subtotal gastrectomy group.

Group Type: ACTIVE_COMPARATOR

Dietary education(nutritional counselling)

Intervention Type: OTHER

Dietary education provided to gastrectomy patients by dietitian.

IE-STG

intensive dietary education arm in subtotal gastrectomy group

Group Type: ACTIVE_COMPARATOR

Dietary education(nutritional counselling)

Intervention Type: OTHER

Dietary education provided to gastrectomy patients by dietitian.

SE-TG

simplified dietary education arm in total gastrectomy group.

Group Type: ACTIVE_COMPARATOR

Dietary education(nutritional counselling)

Intervention Type: OTHER

Dietary education provided to gastrectomy patients by dietitian.

IE-TG

intensive dietary education arm in total gastrectomy group

Group Type: ACTIVE_COMPARATOR

Dietary education(nutritional counselling)

Intervention Type: OTHER

Dietary education provided to gastrectomy patients by dietitian.

Interventions

Dietary education(nutritional counselling)

Dietary education provided to gastrectomy patients by dietitian.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• adequate organ functions defined as indicated below:

1. WBC count: 3000/mm3 ~12,000/mm3,

2. > serum Hemoglobin 8.0 g/dL

3. > serum Platelet 100 000/mm3,

4. < serum AST 100 IU/L,

5. <serum ALT 100 IU/L,

6. < Total Bilirubin 2.0 mg/dL,

• written signed informed consent

Exclusion Criteria

• 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,
• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jae Moon Bae

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aron Lee, RD

Role: STUDY_DIRECTOR

Samsung Medical Center

Bo Ram Park, Ph.D.

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

Samsung medical center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jae-Moon Bae, MD, Ph.D

Role: CONTACT

jmoon.bae@samsung.com

82-2-3410-0252

Aron Lee, RD

Role: CONTACT

82-2-3410-0498

Facility Contacts

Aron Lee

Role: primary

82-2-2148-9802

References

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.

Reference Type: DERIVED

PMID: 41093778 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SMC 2020-11-016-002

Identifier Type: -

Identifier Source: org_study_id