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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Device: Rhexium Onco Nutrition

Detailed Description

1. A total of 4 visits will be performed.
2. 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.
3. 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.
4. During the treatment period, telephone monitoring is conducted depending on the compliance of subjects.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Department of Surgery, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Refer to Title	Week 10 (Visit 4)
Frequency of Adverse Events	Incident rate of Adverse Events will be reported	Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Han-Kwang Yang, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: nutrition; postoperative care; Gastrectomy; Application; Digital health technology
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: HDT-202_F01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No