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

Samsung Medical Center

Status: Enrolling

Conditions: Gastric Cancer; Gastrectomy

Treatments: Other: Dietary education(nutritional counselling)

Study type: Interventional

Funder types: Other

Identifiers

NCT04798820

SMC 2020-11-016-002

Details and patient eligibility

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.

Full 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)

Enrollment: 358 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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358 participants in 4 patient groups

SE-STG

Active Comparator group

Description:

simplified dietary education arm in subtotal gastrectomy group.

Treatment:

Other: Dietary education(nutritional counselling)

IE-STG

Active Comparator group

Description:

intensive dietary education arm in subtotal gastrectomy group

Treatment:

Other: Dietary education(nutritional counselling)

SE-TG

Active Comparator group

Description:

simplified dietary education arm in total gastrectomy group.

Treatment:

Other: Dietary education(nutritional counselling)

IE-TG

Active Comparator group

Description:

intensive dietary education arm in total gastrectomy group

Treatment:

Other: Dietary education(nutritional counselling)