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

Gastric Cancer Clinical Trial

— SING  

Official title:

A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798820
• Other study ID #: SMC 2020-11-016-002
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2021
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Samsung Medical Center
• Contact: Jae-Moon Bae, MD, Ph.D
• Phone: 82-2-3410-0252
• Email: jmoon.bae[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrectomy
• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Dietary education(nutritional counselling)
Dietary education provided to gastrectomy patients by dietitian.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from preoperative weight change at immediate postoperative period in SE and IE groups.	comparison of weight change between the two groups after surgery	preoperative, immediate postoperative
Primary	Change from preoperative weight change at postoperaive 1 month in SE and IE groups.	comparison of weight change between the two groups after surgery	preoperative, postoperative 1 month
Primary	Change from preoperative weight change at postoperaive 3 months in SE and IE groups.	comparison of weight change between the two groups after surgery	preoperative, postoperative 3 months
Primary	Change from preoperative weight change at postoperaive 6 months in SE and IE groups.	comparison of weight change between the two groups after surgery	preoperative, postoperative 6 months
Primary	Change from preoperative weight change at postoperaive 12 months in SE and IE groups.	comparison of weight change between the two groups after surgery	preoperative, postoperative 12 months
Primary	Change from preoperative weight change at postoperaive 18 months in SE and IE groups.	comparison of weight change between the two groups after surgery	preoperative, postoperative 18 months
Secondary	Nutritional parameters	measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	24hrs dietary recall	calculating kcal & protein intake by 24hrs dietary recall (questionnaire)	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	dietary habits	number of meals, eating speed (questionnaire)	preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months
Secondary	Albumin	g/dL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Hemoglobin	g/dL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Total iron binding capacity (TIBC)	µg/dL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Ferritin	ng/mL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Absolute lymphocyte count (ALC)	10^3/µL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Vitamin B12	pg/mL	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Homocysteine	µmol/L	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Secondary	Quality of life of the patients	European quality of life questionnaire (EQ-5D); the descriptive system which comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3).	preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months