NuGa (Nutrition for Gastric Cancer Patients)

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800991
• Other study ID #: HDT-202_F01
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: October 8, 2021

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Frequency of Adverse Events	Incident rate of Adverse Events will be reported	Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
Primary	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)
Primary	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),
Primary	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)
Primary	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	Change from baseline (Visit 1) in 'EORTC QLQ-C30' score	Refer to Title	baseline (Visit 1), Week 10 (Visit 4)
Secondary	Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score	Refer to Title	baseline (Visit 1), Week 10 (Visit 4)
Secondary	Change from baseline (Visit 1) in 'KOQUSS Index' score	Refer to Title	baseline (Visit 1), Week 10 (Visit 4)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The investigational device(application) usage compliance by age	compliance(%) will be measured to day of usage/total period*100	Week 10 (Visit 4)
Secondary	The investigational device(application) usage compliance by gender	compliance(%) will be measured to day of usage/total period*100	Week 10 (Visit 4)
Secondary	The investigational device(application) usage compliance by surgery	compliance(%) will be measured to day of usage/total period*100	Week 10 (Visit 4)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The investigational device(application) usage compliance by underlying disease	compliance(%) will be measured to day of usage/total period*100	Week 10 (Visit 4)