NCT05922566

Brief Summary

This study aims to use the intervention study method to extract and verify the effective ingredients in Mukbang that promote appetite and eating in children with tumor during radiotherapy and chemotherapy, and to analyze and explore their potential mechanisms of action based on functional magnetic resonance imaging.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

May 22, 2023

Last Update Submit

July 23, 2023

Conditions

Children With Cancer

Keywords

childhood cancerMukbangFunctional magnetic resonance imagingappetite

Outcome Measures

Primary Outcomes (1)

  • The pictures of activated functional areas of the brain

    The outcome can be collected using the Siemens 3T Prisma functional Magnetic Resonance Imaging machine with an Inspur data processing system. The pictures reflect the brain functional areas which can be activated by watching Mukbang.

    Baseline

Secondary Outcomes (2)

  • Cancer Appetite and Symptom Questionnaire, CASQ

    Change from baseline appetite at 1 hour intervention

  • The number of increased salivation and perceived appetite

    Change from baseline salivation and perceived appetite during 1 hour fMRI scanning

Study Arms (1)

fMRI scanning while Mukbang watching

EXPERIMENTAL

The fMRI scanning will be divided into 3 parts, includes structural image scans, resting state scans, and task state scans. For the task state function image scanning, participants will be asked to watch the specific video program which includes the food images and eating sound of Mukbang and General short videos without food cues. Healthy kids and children with cancer hospitalized for radiotherapy and chemotherapy will both accept this intervention.

Combination Product: fMRI + Mukbang videos

Interventions

fMRI + Mukbang videosCOMBINATION_PRODUCT

Specific video program + fMRI will be allocated to the participants in this group. The specific video program includes control videos without food information, eating and food images without sound, chewing and swallowing sound without images, and Interactive content in Mukbang. Participants will undergo structural image scans, resting state scans, and task state scans. The task-fMRI will be performed while watching Mukbang to explore the activation of brain functional areas.

fMRI scanning while Mukbang watching

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with cancer aged between 10 to 18 years old;
  • diagnosed with any tumor or cancer other than brain tumor before the age of 18;
  • having received or are receiving inpatient treatment;
  • both the patient and the guardian can communicate in Chinese;
  • children with moderate or higher symptoms of decreased appetite were screened for the Therapy-Related Symptom Checklist for Children.

You may not qualify if:

  • a diagnosis of a serious disease other than a tumor, especially a brain disease such as epilepsy and organic psychosis, was identified from the case;
  • unable to complete communication due to serious mental or physical illness, such as cognitive impairment or unclear consciousness;
  • children with eye or ear dysfunction that prevents them from watching and listening to videos;
  • with braces, cardiac pacemakers and other items with iron magnetism that cannot be removed from the body;
  • people who suffer from claustrophobia, ADHD, and other problems of staying quiet in confined spaces for long periods of time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Wei Xia

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xia

CONTACT

+8618823359471xiaw23@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 28, 2023

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The non-identified individual participant data will be shared after the outcomes have been published.

Shared Documents
SAP
Time Frame
After the publication of the study
Access Criteria
Researchers should contact the PI for approval of the study protocol.

Locations

CN(1)