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

Primary Purpose

Gastric Cancer, Gastrectomy

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dietary education(nutritional counselling)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring gastric cancer, gastrectomy, dietary education, nutritional status

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

SE-STG

IE-STG

SE-TG

IE-TG

Arm Description

simplified dietary education arm in subtotal gastrectomy group.

intensive dietary education arm in subtotal gastrectomy group

simplified dietary education arm in total gastrectomy group.

intensive dietary education arm in total gastrectomy group

Outcomes

Primary Outcome Measures

Change from preoperative weight change at immediate postoperative period in SE and IE groups.
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
comparison of weight change between the two groups after surgery
Change from preoperative weight change at postoperaive 18 months in SE and IE groups.
comparison of weight change between the two groups after surgery

Secondary Outcome Measures

Nutritional parameters
measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)
24hrs dietary recall
calculating kcal & protein intake by 24hrs dietary recall (questionnaire)
dietary habits
number of meals, eating speed (questionnaire)
Albumin
g/dL
Hemoglobin
g/dL
Total iron binding capacity (TIBC)
μg/dL
Ferritin
ng/mL
Absolute lymphocyte count (ALC)
10^3/μL
Vitamin B12
pg/mL
Homocysteine
μmol/L
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).

Full Information

First Posted
March 5, 2021
Last Updated
August 15, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04798820
Brief Title
The Effect of Intensive Dietary Education on Nutritional Status After Gastrectomy(SING)
Acronym
SING
Official Title
A Randomized Clinical Trial of Simplified Dietary Education Versus Intensive Dietary Education on Nutritional Status After Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Nutritional parameters (PG-SGA) the amount of calorie intake (Kcal, protein) & dietary habits Albumin (g/dL) Hemoglobin (g/dL) Iron panel [TIBC (μg/dL), Ferritin (ng/mL)] Absolute lymphocyte count (ALC) (10^3/μL) Vitamin B12 (pg/mL) Homocysteine (μmol/L) Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastrectomy
Keywords
gastric cancer, gastrectomy, dietary education, nutritional status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Simplified dietary education(SE) versus Intensive dietary education(IE) Subtotal gastrectomy group (n=258) Total gastrectomy group (n=100)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SE-STG
Arm Type
Active Comparator
Arm Description
simplified dietary education arm in subtotal gastrectomy group.
Arm Title
IE-STG
Arm Type
Active Comparator
Arm Description
intensive dietary education arm in subtotal gastrectomy group
Arm Title
SE-TG
Arm Type
Active Comparator
Arm Description
simplified dietary education arm in total gastrectomy group.
Arm Title
IE-TG
Arm Type
Active Comparator
Arm Description
intensive dietary education arm in total gastrectomy group
Intervention Type
Other
Intervention Name(s)
Dietary education(nutritional counselling)
Intervention Description
Dietary education provided to gastrectomy patients by dietitian.
Primary Outcome Measure Information:
Title
Change from preoperative weight change at immediate postoperative period in SE and IE groups.
Description
comparison of weight change between the two groups after surgery
Time Frame
preoperative, immediate postoperative
Title
Change from preoperative weight change at postoperaive 1 month in SE and IE groups.
Description
comparison of weight change between the two groups after surgery
Time Frame
preoperative, postoperative 1 month
Title
Change from preoperative weight change at postoperaive 3 months in SE and IE groups.
Description
comparison of weight change between the two groups after surgery
Time Frame
preoperative, postoperative 3 months
Title
Change from preoperative weight change at postoperaive 6 months in SE and IE groups.
Description
comparison of weight change between the two groups after surgery
Time Frame
preoperative, postoperative 6 months
Title
Change from preoperative weight change at postoperaive 12 months in SE and IE groups.
Description
comparison of weight change between the two groups after surgery
Time Frame
preoperative, postoperative 12 months
Title
Change from preoperative weight change at postoperaive 18 months in SE and IE groups.
Description
comparison of weight change between the two groups after surgery
Time Frame
preoperative, postoperative 18 months
Secondary Outcome Measure Information:
Title
Nutritional parameters
Description
measured by Patient-Generated Subjective Global Assessment (PG-SGA; rating A,B,C)
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
24hrs dietary recall
Description
calculating kcal & protein intake by 24hrs dietary recall (questionnaire)
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
dietary habits
Description
number of meals, eating speed (questionnaire)
Time Frame
preoperative, immediate postoperative, postoperative 1 months, 3 months, 6months, 12 months, 18 months
Title
Albumin
Description
g/dL
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Hemoglobin
Description
g/dL
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Total iron binding capacity (TIBC)
Description
μg/dL
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Ferritin
Description
ng/mL
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Absolute lymphocyte count (ALC)
Description
10^3/μL
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Vitamin B12
Description
pg/mL
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Homocysteine
Description
μmol/L
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months
Title
Quality of life of the patients
Description
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).
Time Frame
preoperative, immediate postoperative, postoperative 1 month, 3 months, 6months, 12 months, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Moon Bae, MD, Ph.D
Phone
82-2-3410-0252
Email
jmoon.bae@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aron Lee, RD
Phone
82-2-3410-0498
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aron Lee, RD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Ram Park, Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aron Lee
Phone
82-2-2148-9802

12. IPD Sharing Statement

Plan to Share IPD
No

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

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