NuGa (Nutrition for Gastric Cancer Patients)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Device: Rhexium Onco Nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: HDT-202(application)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhexium Onco Nutrition(HDT-202)<br>subject mobile application and Investigator web portal with no invasive action on the human body | Device: Rhexium Onco Nutrition<br>* The research devices in this study are classified into subject mobile application and investigator web portal with no invasive action on the human body<br>* Other names: HDT-202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | higher scores mean a better outcome | Week 2 (Visit 2) | 
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | higher scores mean a better outcome | Week 6 (Visit 3), | 
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | higher scores mean a better outcome | Week 10 (Visit 4) | 
| Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators | higher scores mean a better outcome | Week 6 (Visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (Visit 1) in 'EORTC QLQ-C30' score | Refer to Title | baseline (Visit 1), Week 10 (Visit 4) | 
| Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score | Refer to Title | baseline (Visit 1), Week 10 (Visit 4) | 
| Change from baseline (Visit 1) in 'KOQUSS Index' score | Refer to Title | baseline (Visit 1), Week 10 (Visit 4) | 
| Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate | Refer to Title | Week 10 (Visit 4) | 
| Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate | Refer to Title | Week 10 (Visit 4) | 
| Frequency of each symptom between visits after using the investigational device (application) | Refer to Title | Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4) | 
| The investigational device(application) usage compliance by age | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) | 
| The investigational device(application) usage compliance by gender | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) | 
| The investigational device(application) usage compliance by surgery | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) | 
| The investigational device(application) usage compliance by stage of disease | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) | 
| 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 | Week 10 (Visit 4) | 
| The investigational device(application) usage compliance by status of postoperative anticancer therapy | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) | 
| The investigational device(application) usage compliance by underlying disease | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrectomy, postoperative care, nutrition, Digital health technology, Application