NuGa (Nutrition for Gastric Cancer Patients)
A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable gastric-cancer
Started Mar 2021
Shorter than P25 for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2021
CompletedOctober 20, 2021
October 1, 2021
7 months
March 10, 2021
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (13)
Change from baseline (Visit 1) in 'EORTC QLQ-C30' score
baseline (Visit 1), Week 10 (Visit 4)
Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score
baseline (Visit 1), Week 10 (Visit 4)
Change from baseline (Visit 1) in 'KOQUSS Index' score
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
Week 10 (Visit 4)
Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate
Week 10 (Visit 4)
- +8 more secondary outcomes
Other Outcomes (2)
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)
Week 10 (Visit 4)
Frequency of Adverse Events
Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
Study Arms (1)
Rhexium Onco Nutrition(HDT-202)
EXPERIMENTAL"subject mobile application" and "Investigator web portal" with no invasive action on the human body
Interventions
The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
Park JH, Lee HJ, Kim J, Cho YS, Lee S, Park S, Choe H, Song E, Kim Y, Kong SH, Park DJ, Nam BH, Yang HK. Development and Feasibility Assessment of Mobile Application-Based Digital Therapeutics for Postoperative Supportive Care in Gastric Cancer Patients Following Gastrectomy. J Gastric Cancer. 2024 Oct;24(4):420-435. doi: 10.5230/jgc.2024.24.e37.
PMID: 39375057DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Kwang Yang, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 16, 2021
Study Start
March 17, 2021
Primary Completion
October 8, 2021
Study Completion
October 8, 2021
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share