Actively Recruiting
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Led by Samsung Medical Center · Updated on 2024-07-15
358
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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histologically proven primary gastric adenocarcinoma,
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T1N0, T1N1, T2N0, which are assessed by computed tomography (CT) scan (AJCC 8th classification) and intraoperative surgical staging
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location of primary tumor; antrum, or angle, , lower body or mid body of the stomach
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No evidence of other distant metastasis,
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age ≥ 20 year old, ≤ 75 year old
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no prior or posterior treatment of chemotherapy or radiation therapy against any other malignancies
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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,
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written signed informed consent
You will not qualify if you...
- 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
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Trial Site Locations
Total: 1 location
1
Samsung medical center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Jae-Moon Bae, MD, Ph.D
CONTACT
A
Aron Lee, RD
CONTACT
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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