Intensive dietary education for improving nutrition after stomach surgery
A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
NA · Samsung Medical Center · NCT04798820
This study tests whether a more detailed dietary education helps people who have had stomach surgery for cancer maintain their weight and improve their nutrition better than simpler advice.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04798820 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of intensive dietary education on nutritional status in patients who have undergone gastrectomy due to gastric cancer. It compares the effectiveness of simplified dietary education against a more intensive approach in preventing weight loss and improving various nutritional parameters post-surgery. The primary objective is to assess the weight loss difference between the two educational approaches over a 12-month period, while secondary objectives include evaluating changes in nutritional parameters, calorie intake, and quality of life. The study aims to provide insights into the best dietary practices for enhancing recovery and health outcomes in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 with histologically confirmed primary gastric adenocarcinoma who are undergoing gastrectomy.
Not a fit: Patients with active double cancer or those who have received prior treatment for other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve nutritional outcomes and quality of life for patients recovering from gastrectomy.
How similar studies have performed: Previous studies have indicated that dietary education can positively influence recovery in surgical patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Samsung medical center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jae-Moon Bae, MD, Ph.D
- Email: jmoon.bae@samsung.com
- Phone: 82-2-3410-0252
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Cancer, Gastrectomy, gastric cancer, gastrectomy, dietary education, nutritional status