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

Launched by SAMSUNG MEDICAL CENTER · Mar 12, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy," is investigating how different levels of dietary education impact the nutrition and overall health of patients who have undergone surgery for gastric cancer. After a gastrectomy (surgery to remove part or all of the stomach), patients often face challenges like weight loss and malnutrition, which can affect their recovery and quality of life. The study compares the effects of intensive dietary education, which provides detailed guidance on nutrition, against simpler dietary advice to see which is more effective in helping patients maintain their nutritional status.

To be eligible for this trial, participants must be adults aged 20 to 75 who have been diagnosed with a specific type of stomach cancer, have no signs of cancer spreading to other parts of the body, and meet certain health criteria. Participants will receive either intensive or simplified dietary education and will be monitored for changes in their nutritional status after surgery. This trial is currently recruiting participants and aims to find the best way to support patients' health and recovery following gastrectomy.

Gender

ALL

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