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OpenTrials
Completed

NCT Number: NCT04800991

NuGa (Nutrition for Gastric Cancer Patients)

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Rhexium Onco Nutrition

Device

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

Primary outcomes

  1. 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

  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

  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

  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

Secondary outcomes

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

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

    Refer to Title

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

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

    Refer to Title

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

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

    Refer to Title

  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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

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)

    Time frame: Week 10 (Visit 4)

    Refer to Title

  2. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2021
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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