Children With CancerNCT05922566
Research on the Influence of Mukbang on Brain Activation in Children With Cancer Based on fMRI
A study testing fMRI + Mukbang videos in people with Children With Cancer, run by Wei XIA, PhD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Cancer
- What is being tested?
- fMRI + Mukbang videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Nov 2023
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Exploration of the Effect of Mukbang on Functional Connectivity of Related Brain Regions in Children With Cancer Hospitalized for Radiotherapy and Chemotherapy Based on fMRI
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.
Read the detailed description
Cancer has a high incidence among children and adolescents worldwide. In October 2020, the World Health Organization (WHO) released an overview of the Global Action on Childhood Cancer which showed that more than 400,000 children under the age of 19 were diagnosed with cancer worldwide every year. With the development and progress of diagnosis and treatment technology, the health outcome of children with cancer has been greatly improved.
However, the side effects and complications associated with cancer and its treatment can seriously affect the appetite and food intake of children with cancer, resulting in malnutrition and a low quality of life. Therefore, it is very important to effectively improve the appetite of children with cancer during treatment.
Clinical methods to improve the appetite of cancer patients mainly include drugs, diet or nutrition intervention, traditional Chinese medicine and acupuncture, but each intervention has its own advantages and disadvantages which makes the clinical application effect difficult to evaluate, in urgent need of more effective solutions to solve this problem.
Mukbang has shown great potential in helping children with cancer to improve their appetite and food consumption, finally promote nutritional health. Mukbang is a method independently chosen by hospitalized cancer children with radiotherapy and chemotherapy to help promote appetite, which has a natural high acceptance. What's more, the features of Mukbang, such as high-quality and clear pictures, relaxed atmosphere created by the video makers, sounds while eating, and attractive images of food, may promote viewers' appetite and increase their intake imperceptibly.
In addition to that, watching Mukbang while eating can also provide a pleasant eating experience for children with cancer, and the interaction with the Mukbang anchor can also alleviate the loneliness of children who live in hospital for such a long time, so as to enhance the children's taste experience, relieve the negative emotions of loneliness and depression and promote their appetite and interest in food under the condition of ensuring a healthy diet.
Research has found that Mukbang can help people with low appetites increase their food intake and provide vicarious satisfaction to those who overeat. Several studies have shown that videos containing food cues can increase viewers' appetite and decrease feelings of satiety to a certain extent. At the same time, Mukbang can also increase viewers' taste experience on the basis of physics and improve children's interest in food.
Therefore, on the basis of existing studies, this study will use functional magnetic resonance imaging and cross-case analysis to extract and verify the effective ingredients in Mukbang that promote appetite and eating in children with tumor during radiotherapy and chemotherapy, and analyze and discuss their potential mechanism of action, aiming to provide a new direction for clinical departments to develop nutritional intervention measures and management programs for children with cancer.
- Conditions
- Children With Cancer
- Being tested
- fMRI + Mukbang videos
- Keywords
- childhood cancer, Mukbang, Functional magnetic resonance imaging, appetite
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: fMRI + Mukbang videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (2)
Cancer Appetite and Symptom Questionnaire, CASQ
Participants' self-reported appetite, to reflect the participants' own perceived appetite.
Measured: Change from baseline appetite at 1 hour intervention
The number of increased salivation and perceived appetite
In order to further evaluate the relationship between the functional activities of the appetition-related regions of the brain and appetite, the number of salivation and increased perceived appetite will be recorded by pressing the button during the MRI scan.
Measured: Change from baseline salivation and perceived appetite during 1 hour fMRI scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study startAug 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922566
- Sponsor's protocol ID
- fMRI
- Status last verified
- Jul 2023
- First submitted
- 22 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified individual participant data will be shared after the outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploration of the Effect of Mukbang on Functional Connectivity of Related Brain Regions in Children With Cancer Hospitalized for Radiotherapy and Chemotherapy Based on fMRI
- ClinicalTrials.gov ID
- NCT05922566
- Acronym / sponsor ID
- fMRI
- Conditions
- Children With Cancer
- Keywords
- childhood cancer, Mukbang, Functional magnetic resonance imaging, appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cancer has a high incidence among children and adolescents worldwide. In October 2020, the World Health Organization (WHO) released an overview of the Global Action on Childhood Cancer which showed that more than 400,000 children under the age of 19 were diagnosed with cancer worldwide every year. With the development and progress of diagnosis and treatment technology, the health outcome of children with cancer has been greatly improved.
However, the side effects and complications associated with cancer and its treatment can seriously affect the appetite and food intake of children with cancer, resulting in malnutrition and a low quality of life. Therefore, it is very important to effectively improve the appetite of children with cancer during treatment.
Clinical methods to improve the appetite of cancer patients mainly include drugs, diet or nutrition intervention, traditional Chinese medicine and acupuncture, but each intervention has its own advantages and disadvantages which makes the clinical application effect difficult to evaluate, in urgent need of more effective solutions to solve this problem.
Mukbang has shown great potential in helping children with cancer to improve their appetite and food consumption, finally promote nutritional health. Mukbang is a method independently chosen by hospitalized cancer children with radiotherapy and chemotherapy to help promote appetite, which has a natural high acceptance. What's more, the features of Mukbang, such as high-quality and clear pictures, relaxed atmosphere created by the video makers, sounds while eating, and attractive images of food, may promote viewers' appetite and increase their intake imperceptibly.
In addition to that, watching Mukbang while eating can also provide a pleasant eating experience for children with cancer, and the interaction with the Mukbang anchor can also alleviate the loneliness of children who live in hospital for such a long time, so as to enhance the children's taste experience, relieve the negative emotions of loneliness and depression and promote their appetite and interest in food under the condition of ensuring a healthy diet.
Research has found that Mukbang can help people with low appetites increase their food intake and provide vicarious satisfaction to those who overeat. Several studies have shown that videos containing food cues can increase viewers' appetite and decrease feelings of satiety to a certain extent. At the same time, Mukbang can also increase viewers' taste experience on the basis of physics and improve children's interest in food.
Therefore, on the basis of existing studies, this study will use functional magnetic resonance imaging and cross-case analysis to extract and verify the effective ingredients in Mukbang that promote appetite and eating in children with tumor during radiotherapy and chemotherapy, and analyze and discuss their potential mechanism of action, aiming to provide a new direction for clinical departments to develop nutritional intervention measures and management programs for children with cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI scanning while Mukbang watching | Experimental | Combination Product: fMRI + Mukbang videosThe 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI + Mukbang videosSpecific 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. | Combination product | fMRI scanning while Mukbang watching |
Primary outcome
The pictures of activated functional areas of the brain
Time frame: Baseline
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.
2 secondary outcomes
Cancer Appetite and Symptom Questionnaire, CASQ
Time frame: Change from baseline appetite at 1 hour intervention
The number of increased salivation and perceived appetite
Time frame: Change from baseline salivation and perceived appetite during 1 hour fMRI scanning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Yes. The non-identified individual participant data will be shared after the outcomes have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xia principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI + Mukbang videos in people with Children With Cancer, run by Wei XIA, PhD at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia (+8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pictures of activated functional areas of the brain (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.