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

Study Overview
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Brief Summary
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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
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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)

Official Title
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A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy

Conditions
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Gastric Cancer, Gastrectomy

Intervention / Treatment
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* Other: Dietary education(nutritional counselling)


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Simplified dietary education(SE) versus Intensive dietary education(IE) Subtotal gastrectomy group (n=258) Total gastrectomy group (n=100)
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, gastrectomy, dietary education, nutritional status