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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Gastrectomy
• Intervention / Treatment: Other: Dietary education(nutritional counselling)

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)

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jae-Moon Bae, MD, Ph.D; Phone Number: 82-2-3410-0252; Email: jmoon.bae@samsung.com
• Study Contact Backup: Name: Aron Lee, RD; Phone Number: 82-2-3410-0498

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Aron Lee; Phone Number: 82-2-2148-9802

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SE-STG; simplified dietary education arm in subtotal gastrectomy group.	Other: Dietary education(nutritional counselling); Dietary education provided to gastrectomy patients by dietitian.
Active Comparator: IE-STG; intensive dietary education arm in subtotal gastrectomy group	Other: Dietary education(nutritional counselling); Dietary education provided to gastrectomy patients by dietitian.
Active Comparator: SE-TG; simplified dietary education arm in total gastrectomy group.	Other: Dietary education(nutritional counselling); Dietary education provided to gastrectomy patients by dietitian.
Active Comparator: IE-TG; intensive dietary education arm in total gastrectomy group	Other: Dietary education(nutritional counselling); Dietary education provided to gastrectomy patients by dietitian.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional parameters	measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)	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)	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
dietary habits	number of meals, eating speed (questionnaire)	preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months
Albumin	g/dL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Hemoglobin	g/dL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Total iron binding capacity (TIBC)	μg/dL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Ferritin	ng/mL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Absolute lymphocyte count (ALC)	10^3/μL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Vitamin B12	pg/mL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Homocysteine	μmol/L	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).	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Director: Aron Lee, RD, Samsung Medical Center; Study Director: Bo Ram Park, Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: nutritional status; gastric cancer; gastrectomy; dietary education
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: SMC 2020-11-016-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No