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Gastric CancerNCT04800991

NuGa (Nutrition for Gastric Cancer Patients)

A study testing Rhexium Onco Nutrition in people with Gastric Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Rhexium Onco Nutrition
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
17 Mar 2021to 8 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Surgery, Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

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

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.
Conditions
Gastric Cancer
Being tested
Rhexium Onco Nutrition
Keywords
Gastrectomy, postoperative care, nutrition, Digital health technology, Application
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rhexium Onco NutritionDevice

    Also called HDT-202

    The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body

Study groups in NCT04800991
Study groupRoleWhat they receive
Rhexium Onco Nutrition(HDT-202)Experimental"subject mobile application" and "Investigator web portal" with no invasive action on the human body
Receives: Device: Rhexium Onco Nutrition

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    higher scores mean a better outcome

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Week 6 (Visit 3)

Secondary outcomes (13)

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

    Refer to Title

    Measured: baseline (Visit 1), Week 10 (Visit 4)

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

    Refer to Title

    Measured: baseline (Visit 1), Week 10 (Visit 4)

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

    Refer to Title

    Measured: 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

    Measured: 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

    Measured: Week 10 (Visit 4)

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

    Refer to Title

    Measured: 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

    Measured: Week 10 (Visit 4)

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

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

    Measured: Week 10 (Visit 4)

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Week 10 (Visit 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start17 Mar 2021
  3. Primary completion8 Oct 2021
  4. Study completion8 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
HDT-202(application)
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04800991
Sponsor's protocol ID
HDT-202_F01
Status last verified
Oct 2021
First submitted
10 Mar 2021
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39375057

Questions about this trial

What is this clinical trial studying?

A study testing Rhexium Onco Nutrition in people with Gastric Cancer, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects (time frame: Week 2 (Visit 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04800991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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