Gastrectomy, Gastric Cancer
Conditions
Keywords
gastric cancer, gastrectomy, dietary education, nutritional status
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)
Interventions
OTHERDietary education(nutritional counselling)
Dietary education provided to gastrectomy patients by dietitian.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double blind
Intervention model description
Simplified dietary education(SE) versus Intensive dietary education(IE) 1. Subtotal gastrectomy group (n=258) 2. Total gastrectomy group (n=100)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from preoperative weight change at immediate postoperative period in SE and IE groups. | 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. | 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. | 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. | 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. | 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. | preoperative, postoperative 18 months | comparison of weight change between the two groups after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ferritin | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | ng/mL |
| Absolute lymphocyte count (ALC) | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | 10\^3/μL |
| Nutritional parameters | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C) |
| Homocysteine | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | μmol/L |
| Quality of life of the patients | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | 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). |
| Vitamin B12 | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | pg/mL |
| 24hrs dietary recall | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | calculating kcal & protein intake by 24hrs dietary recall (questionnaire) |
| dietary habits | preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months | number of meals, eating speed (questionnaire) |
| Albumin | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | g/dL |
| Hemoglobin | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | g/dL |
| Total iron binding capacity (TIBC) | preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months | μg/dL |
Countries
South Korea
Contacts
Primary ContactJae-Moon Bae, MD, Ph.D
Backup ContactAron Lee, RD
Outcome results
None listed