Clinical trial NCT04798820: The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Official title: A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Gastrectomy
Keywords: gastric cancer
gastrectomy
dietary education
nutritional status
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 358
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simplified dietary education(SE) versus Intensive dietary education(IE)

1. Subtotal gastrectomy group (n=258)
2. Total gastrectomy group (n=100)
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: Change from preoperative weight change at immediate postoperative period in SE and IE groups.
timeFrame: preoperative, immediate postoperative
measure: Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
timeFrame: preoperative, postoperative 1 month
measure: Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
timeFrame: preoperative, postoperative 3 months
measure: Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
timeFrame: preoperative, postoperative 6 months
measure: Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
timeFrame: preoperative, postoperative 12 months
measure: Change from preoperative weight change at postoperaive 18 months in SE and IE groups.
timeFrame: preoperative, postoperative 18 months
Secondary outcomes:
measure: Nutritional parameters
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: 24hrs dietary recall
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: dietary habits
timeFrame: preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months
measure: Albumin
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Hemoglobin
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Total iron binding capacity (TIBC)
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Ferritin
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Absolute lymphocyte count (ALC)
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Vitamin B12
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Homocysteine
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
measure: Quality of life of the patients
timeFrame: preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Aron Lee, RD
role: STUDY_DIRECTOR
affiliation: Samsung Medical Center
name: Bo Ram Park, Ph.D.
role: STUDY_DIRECTOR
References: