Nutritional Counseling for Patients With Gastric Cancer After Subtotal Gastrectomy: A Randomized Clinical Trial.
Ah Ron Lee, Jae-Moon Bae, Min-Gew Choi...
https://pubmed.ncbi.nlm.nih.gov/41093778Actively Recruiting
Phase Not Applicable
Age: 20Years - 75Years
All Genders
ID04798820
A Randomized Clinical Trial Comparing Simplified Versus Intensive Dietary Education on Nutritional Status After Gastrectomy for Gastric Cancer
Led by Samsung Medical Center · Updated on 2024-07-15
358
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of intensive dietary education on nutritional status after gastrectomy in patients with gastric cancer. Radical gastrectomy is a common treatment for curable gastric cancer but often leads to malnutrition and weight loss, which can affect recovery and quality of life. Previous studies suggest that simple dietary education may not be enough, so this trial compares more intensive dietary counseling to simplified education to see if it better supports patients' nutrition. Participants are divided into four groups based on the type of gastrectomy (subtotal or total) and the level of dietary education received (simplified or intensive). Dietary education is provided by dietitians, aiming to help patients maintain weight and nutritional health after surgery. The study measures weight loss and other nutritional parameters over time, comparing intensive versus simplified education effects. During the study, patients' weight change is tracked from before surgery through multiple postoperative time points up to 18 months. Researchers also assess dietary intake, blood nutritional markers, and quality of life using questionnaires. The study involves regular evaluations of nutritional status, including calorie intake, blood tests for albumin, hemoglobin, iron levels, vitamin B12, and homocysteine, as well as quality of life assessments. This comprehensive monitoring helps determine the effectiveness of dietary education approaches in supporting recovery after gastrectomy.
CONDITIONS
Brief Title
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Who Can Participate
Age: 20Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary gastric adenocarcinoma
- Tumor stages T1N0, T1N1, or T2N0 assessed by CT scan and surgical staging
- Tumor located in antrum, angle, lower body, or mid body of the stomach
- No distant metastasis
- Age between 20 and 75 years
- No prior or planned chemotherapy or radiation for other cancers
- Adequate organ function: WBC count 3000-12000/mm3, hemoglobin >8.0 g/dL, platelets >100,000/mm3, AST <100 IU/L, ALT <100 IU/L, total bilirubin <2.0 mg/dL
- Signed informed consent
You will not qualify if you...
- Active double cancer within five years, except carcinoma in situ
- Gastric remnant cancer
- Tumor stage T3 or higher before surgery
- N2 or more lymph node metastasis on CT scan
- Rare histological variants like adenosquamous, hepatoid, squamous cell, undifferentiated, neuroendocrine carcinoma
- Pregnant or breastfeeding women
- Diagnosed mental disorders
- Unstable angina or recent myocardial infarction within 6 months
- Unstable hypertension
- Insulin-dependent diabetes mellitus
- Severe respiratory disease requiring oxygen therapy
- Prior upper abdominal surgery except laparoscopic cholecystectomy
- Surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 18 months after surgery
Participants receive either simplified or intensive dietary education by a dietitian after undergoing subtotal or total gastrectomy.
Visits at immediate postoperative period, 1 month, 3 months, 6 months, 12 months, and 18 months
Trial Site Locations
Total: 1 location
1
Samsung medical center
Seoul, South Korea, 06351
Actively Recruiting
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Research Team
J
Jae-Moon Bae, MD, Ph.D
A
Aron Lee, RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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