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NuGa (Nutrition for Gastric Cancer Patients)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rhexium Onco Nutrition
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring Gastrectomy, postoperative care, nutrition, Digital health technology, Application

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient who voluntarily signs the informed consent form for this study
  2. Age of ≥19 years old
  3. Patient who has undergone therapeutic gastrectomy after a diagnosis of gastric cancer
  4. Able to eat food orally after gastrectomy
  5. Patient who possesses an Android OS based mobile device and is capable of using the investigational device.

Exclusion Criteria:

  1. Other cancer or metastasis documented within 5 years prior to screening
  2. Ongoing or planned enteral tube feeding or total parenteral nutrition
  3. Other clinically significant medical or psychiatric findings based on which the individual is considered by the investigator to be ineligible
  4. Individual who possesses a mobile device on which the application is unable to be installed and/or run normally for technical reasons
  5. Individual who, in the opinion of the investigator, has difficulty understanding how to use the investigational device or is unlikely to comply with other study procedures

Sites / Locations

  • Department of Surgery, Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rhexium Onco Nutrition(HDT-202)

Arm Description

"subject mobile application" and "Investigator web portal" with no invasive action on the human body

Outcomes

Primary Outcome Measures

Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
higher scores mean a better outcome
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
higher scores mean a better outcome
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
higher scores mean a better outcome
Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators
higher scores mean a better outcome

Secondary Outcome Measures

Change from baseline (Visit 1) in 'EORTC QLQ-C30' score
Refer to Title
Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score
Refer to Title
Change from baseline (Visit 1) in 'KOQUSS Index' score
Refer to Title
Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate
Refer to Title
Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate
Refer to Title
Frequency of each symptom between visits after using the investigational device (application)
Refer to Title
The investigational device(application) usage compliance by age
compliance(%) will be measured to day of usage/total period*100
The investigational device(application) usage compliance by gender
compliance(%) will be measured to day of usage/total period*100
The investigational device(application) usage compliance by surgery
compliance(%) will be measured to day of usage/total period*100
The investigational device(application) usage compliance by stage of disease
compliance(%) will be measured to day of usage/total period*100
The investigational device(application) usage compliance by body mass index [BMI] before discharge from hospital
weight and height will be combined to report BMI in kg/m^2, compliance(%) will be measured to day of usage/total period*100
The investigational device(application) usage compliance by status of postoperative anticancer therapy
compliance(%) will be measured to day of usage/total period*100
The investigational device(application) usage compliance by underlying disease
compliance(%) will be measured to day of usage/total period*100

Full Information

First Posted
March 10, 2021
Last Updated
October 19, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04800991
Brief Title
NuGa (Nutrition for Gastric Cancer Patients)
Official Title
A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

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
The objective of this pilot study is to evaluate the feasibility and efficacy of Rhexium Onco Nutrition, HDT-202 for post-operative care in patients who have undergone gastrectomy.
Detailed Description
A total of 4 visits will be performed. At the screening visit,subject's written informed consent, assessing the inclusion/exclusion criteria and assigning enrollment numbers to eligible subjects, demographic information taking, medical history/medication history taking, vital signs measuring, physical examination, height and body weight measuring, instructing how to install/use the investigational device, and administering quality of life questionnaires. During the treatment period, a total of 3 visits will be performed. To evaluate feasibility and efficacy, the following procedures will be carried out: vital signs measuring, physical examination, nutrition assessment/consultation, evaluation of feasibility for 'subjects', evaluation of feasibility for 'investigators', and adverse events (AEs)/concomitant medications checking and collecting. During the treatment period, telephone monitoring is conducted depending on the compliance of subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastrectomy, postoperative care, nutrition, Digital health technology, Application

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
HDT-202(application)
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhexium Onco Nutrition(HDT-202)
Arm Type
Experimental
Arm Description
"subject mobile application" and "Investigator web portal" with no invasive action on the human body
Intervention Type
Device
Intervention Name(s)
Rhexium Onco Nutrition
Other Intervention Name(s)
HDT-202
Intervention Description
The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body
Primary Outcome Measure Information:
Title
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
Description
higher scores mean a better outcome
Time Frame
Week 2 (Visit 2)
Title
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
Description
higher scores mean a better outcome
Time Frame
Week 6 (Visit 3),
Title
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
Description
higher scores mean a better outcome
Time Frame
Week 10 (Visit 4)
Title
Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators
Description
higher scores mean a better outcome
Time Frame
Week 6 (Visit 3)
Secondary Outcome Measure Information:
Title
Change from baseline (Visit 1) in 'EORTC QLQ-C30' score
Description
Refer to Title
Time Frame
baseline (Visit 1), Week 10 (Visit 4)
Title
Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score
Description
Refer to Title
Time Frame
baseline (Visit 1), Week 10 (Visit 4)
Title
Change from baseline (Visit 1) in 'KOQUSS Index' score
Description
Refer to Title
Time Frame
baseline (Visit 1), Week 10 (Visit 4)
Title
Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate
Description
Refer to Title
Time Frame
Week 10 (Visit 4)
Title
Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate
Description
Refer to Title
Time Frame
Week 10 (Visit 4)
Title
Frequency of each symptom between visits after using the investigational device (application)
Description
Refer to Title
Time Frame
Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by age
Description
compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by gender
Description
compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by surgery
Description
compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by stage of disease
Description
compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by body mass index [BMI] before discharge from hospital
Description
weight and height will be combined to report BMI in kg/m^2, compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by status of postoperative anticancer therapy
Description
compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Title
The investigational device(application) usage compliance by underlying disease
Description
compliance(%) will be measured to day of usage/total period*100
Time Frame
Week 10 (Visit 4)
Other Pre-specified Outcome Measures:
Title
Frequency of each symptom by baseline characteristics (age, gender, surgery, stage of disease, BMI before discharge from hospital, status of postoperative anticancer therapy, underlying disease)
Description
Refer to Title
Time Frame
Week 10 (Visit 4)
Title
Frequency of Adverse Events
Description
Incident rate of Adverse Events will be reported
Time Frame
Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient who voluntarily signs the informed consent form for this study Age of ≥19 years old Patient who has undergone therapeutic gastrectomy after a diagnosis of gastric cancer Able to eat food orally after gastrectomy Patient who possesses an Android OS based mobile device and is capable of using the investigational device. Exclusion Criteria: Other cancer or metastasis documented within 5 years prior to screening Ongoing or planned enteral tube feeding or total parenteral nutrition Other clinically significant medical or psychiatric findings based on which the individual is considered by the investigator to be ineligible Individual who possesses a mobile device on which the application is unable to be installed and/or run normally for technical reasons Individual who, in the opinion of the investigator, has difficulty understanding how to use the investigational device or is unlikely to comply with other study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Kwang Yang, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NuGa (Nutrition for Gastric Cancer Patients)

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