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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05922566
Other study ID # fMRI
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2023
Est. completion date November 2023

Study information

Verified date July 2023
Source Sun Yat-sen University
Contact Wei Xia
Phone +8618823359471
Email xiaw23@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date November 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
fMRI + Mukbang videos
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.

Locations

Country Name City State
China Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Wei XIA, PhD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cancer Appetite and Symptom Questionnaire, CASQ Participants' self-reported appetite, to reflect the participants' own perceived appetite. Change from baseline appetite at 1 hour intervention
Secondary 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. Change from baseline salivation and perceived appetite during 1 hour fMRI scanning
See also
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Not yet recruiting NCT05922553 - Using Mukbang to Improve Appetite, Nutritional Status and Quality of Life in Children With Cancer N/A