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

NCT04798820 | Recruiting

• 1 other identifier: SMC 2020-11-016-002
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Gastrectomy

Keywords

gastric cancer; gastrectomy; dietary education; nutritional status

Outcome Measures

Primary Outcomes (6)

• Change from preoperative weight change at immediate postoperative period in SE and IE groups.

  comparison of weight change between the two groups after surgery

  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

  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

  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

  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

  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

  preoperative, postoperative 18 months

Secondary Outcomes (11)

• Nutritional parameters

  preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months

• 24hrs dietary recall

  preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months

• dietary habits

  preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months

• Albumin

  preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months

• Hemoglobin

  preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months

Study Arms (4)

SE-STG

ACTIVE COMPARATOR

simplified dietary education arm in subtotal gastrectomy group.

Other: Dietary education(nutritional counselling)

IE-STG

ACTIVE COMPARATOR

intensive dietary education arm in subtotal gastrectomy group

Other: Dietary education(nutritional counselling)

SE-TG

ACTIVE COMPARATOR

simplified dietary education arm in total gastrectomy group.

Other: Dietary education(nutritional counselling)

IE-TG

ACTIVE COMPARATOR

intensive dietary education arm in total gastrectomy group

Other: Dietary education(nutritional counselling)

Interventions

Dietary education(nutritional counselling) OTHER

Dietary education provided to gastrectomy patients by dietitian.

IE-STG; IE-TG; SE-STG; SE-TG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 41093778 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Aron Lee, RD

  Samsung Medical Center

  STUDY DIRECTOR

• Bo Ram Park, Ph.D.

  Samsung Medical Center

  STUDY DIRECTOR

Central Study Contacts

Jae-Moon Bae, MD, Ph.D

CONTACT

82-2-3410-0252; jmoon.bae@samsung.com

Aron Lee, RD

CONTACT

82-2-3410-0498

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Simplified dietary education(SE) versus Intensive dietary education(IE) 1. Subtotal gastrectomy group (n=258) 2. Total gastrectomy group (n=100)

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 15, 2021
• Study Start: March 9, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)