CClinicalTrials.gg
Sign In
CompletedNCT04800991Updated Oct 20, 2021

NuGa (Nutrition for Gastric Cancer Patients)

An interventional study of Rhexium Onco Nutrition in Gastric Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Gastric Cancer

Browse trials for

Keywords

  • Gastrectomy
  • postoperative care
  • nutrition
  • Digital health technology
  • Application
03

In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's enrollment of 40 is below the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • DeviceRhexium 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

    Also known as: HDT-202

06

What researchers measure

Primary outcomes

  1. Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects

    higher scores mean a better outcome

    Time frame: Week 2 (Visit 2)

  2. Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects

    higher scores mean a better outcome

    Time frame: Week 6 (Visit 3),

  3. Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects

    higher scores mean a better outcome

    Time frame: Week 10 (Visit 4)

  4. Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators

    higher scores mean a better outcome

    Time frame: Week 6 (Visit 3)

Secondary outcomes

  1. Change from baseline (Visit 1) in 'EORTC QLQ-C30' score

    Refer to Title

    Time frame: baseline (Visit 1), Week 10 (Visit 4)

  2. Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score

    Refer to Title

    Time frame: baseline (Visit 1), Week 10 (Visit 4)

  3. Change from baseline (Visit 1) in 'KOQUSS Index' score

    Refer to Title

    Time frame: baseline (Visit 1), Week 10 (Visit 4)

  4. Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate

    Refer to Title

    Time frame: Week 10 (Visit 4)

  5. Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate

    Refer to Title

    Time frame: Week 10 (Visit 4)

  6. Frequency of each symptom between visits after using the investigational device (application)

    Refer to Title

    Time frame: Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)

  7. The investigational device(application) usage compliance by age

    compliance(%) will be measured to day of usage/total period\*100

    Time frame: Week 10 (Visit 4)

  8. The investigational device(application) usage compliance by gender

    compliance(%) will be measured to day of usage/total period\*100

    Time frame: Week 10 (Visit 4)

  9. The investigational device(application) usage compliance by surgery

    compliance(%) will be measured to day of usage/total period\*100

    Time frame: Week 10 (Visit 4)

  10. The investigational device(application) usage compliance by stage of disease

    compliance(%) will be measured to day of usage/total period\*100

    Time frame: Week 10 (Visit 4)

  11. 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

    Time frame: Week 10 (Visit 4)

  12. The investigational device(application) usage compliance by status of postoperative anticancer therapy

    compliance(%) will be measured to day of usage/total period\*100

    Time frame: Week 10 (Visit 4)

  13. The investigational device(application) usage compliance by underlying disease

    compliance(%) will be measured to day of usage/total period\*100

    Time frame: Week 10 (Visit 4)

Other outcomes

  1. 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

    Time frame: Week 10 (Visit 4)

  2. Frequency of Adverse Events

    Incident rate of Adverse Events will be reported

    Time frame: Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)

07

Study locations

1 site
  • Department of Surgery, Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04800991
Lead sponsor
Seoul National University Hospital
Responsible party
Han-Kwang Yang (Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 16, 2021
Start date
Mar 17, 2021
Primary completion
Oct 8, 2021
Completion
Oct 8, 2021
Last update
Oct 20, 2021

Study contacts

Han-Kwang Yang, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stomach Neoplasms→

Other studies from this sponsor

Seoul National University Hospital

Start the discussion