NuGa (Nutrition for Gastric Cancer Patients)

October 19, 2021 updated by: Han-Kwang Yang, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
Time Frame: Week 2 (Visit 2)
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
Time Frame: Week 6 (Visit 3),
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
Time Frame: Week 10 (Visit 4)
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
Time Frame: Week 6 (Visit 3)
higher scores mean a better outcome
Week 6 (Visit 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline (Visit 1) in 'EORTC QLQ-C30' score
Time Frame: baseline (Visit 1), Week 10 (Visit 4)
Refer to Title
baseline (Visit 1), Week 10 (Visit 4)
Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score
Time Frame: baseline (Visit 1), Week 10 (Visit 4)
Refer to Title
baseline (Visit 1), Week 10 (Visit 4)
Change from baseline (Visit 1) in 'KOQUSS Index' score
Time Frame: baseline (Visit 1), Week 10 (Visit 4)
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
Time Frame: Week 10 (Visit 4)
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
Time Frame: Week 10 (Visit 4)
Refer to Title
Week 10 (Visit 4)
Frequency of each symptom between visits after using the investigational device (application)
Time Frame: Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
Refer to Title
Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
The investigational device(application) usage compliance by age
Time Frame: Week 10 (Visit 4)
compliance(%) will be measured to day of usage/total period*100
Week 10 (Visit 4)
The investigational device(application) usage compliance by gender
Time Frame: Week 10 (Visit 4)
compliance(%) will be measured to day of usage/total period*100
Week 10 (Visit 4)
The investigational device(application) usage compliance by surgery
Time Frame: Week 10 (Visit 4)
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
Time Frame: Week 10 (Visit 4)
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
Time Frame: Week 10 (Visit 4)
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
Time Frame: Week 10 (Visit 4)
compliance(%) will be measured to day of usage/total period*100
Week 10 (Visit 4)
The investigational device(application) usage compliance by underlying disease
Time Frame: Week 10 (Visit 4)
compliance(%) will be measured to day of usage/total period*100
Week 10 (Visit 4)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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)
Time Frame: Week 10 (Visit 4)
Refer to Title
Week 10 (Visit 4)
Frequency of Adverse Events
Time Frame: Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
Incident rate of Adverse Events will be reported
Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Han-Kwang Yang, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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