Health Outcomes of Nasopharyngeal Carcinoma Patients Three Years After Treatment by the AI-assisted Home Enteral Nutrition Management

September 18, 2024 updated by: Danna Chen, Changsha Medical University
You have completed the current stage of cancer treatment, after which you need to check regularly and pay attention to nutrition. So we started this study to see if AI could help with nutrition management. Main options: Option 1: Use AI to assist nutrition management; Option 2: Contact the nutritionist team of the hospital for nutrition management according to your own situation. Option 3: Do not adopt the first two management methods. Special Statement: Please choose; Cancer screening data is used for statistical analysis, but does not reveal any personal privacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zhengzhou, China
        • First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Malignant tumor patient

Exclusion Criteria:

  • no

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1: Use AI to assist nutrition management

The first step: Preliminary clinical nutrition screening and evaluation. Information of patients' age, stage of nasopharyngeal cancer, treatment stage (radiotherapy, chemotherapy stage) and other information were collected, and the management plan was determined.

The second step: AI-assisted HEN management mode. Regular nutritional monitoring and follow-up of patients were conducted by means of intelligent computer, intelligent App body fat device and mobile communication network collection, and basic signs, nutritional status, nutritional risks and implementation of support programs of patients were managed. Nutritional analysis model and index model are used to start the intelligent daily monitoring management and acute attack early warning mechanism.

The third step: Monitor and alert. The AI system popularized the basic knowledge of nutrition to patients through the App platform.
Other: group 1: Use AI to assist nutrition management
group1：AI-assisted nutrition management. group 2：Traditional nutrition management（through the hospital dietitian）.group 3:control.
Experimental: group 2: Contact the nutritionist team of the hospital for nutrition management
Contact the nutritionist team of the hospital for nutrition management according to patients' own situation
Other: group 2：Traditional nutrition management（through the hospital dietitian）
group 2：Traditional nutrition management（through the hospital dietitian）
No Intervention: group 3: Do not adopt the two management methods.
blank control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate
Time Frame: three years after treatment
Survival Rate
three years after treatment
Local Recurrence Rate
Time Frame: three years after treatment
Local Recurrence Rate
three years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DNA positive rate of Epstein-Barr(EB) virus
Time Frame: three years after treatment
DNA positive rate of Epstein-Barr(EB) virus
three years after treatment
Body mass index
Time Frame: three years after treatment
Data was obtained through the intelligent body fat device
three years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changsha Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-nutrition to NPC patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publish the paper publicly so that more people can learn about the results of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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