NCT06603909

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.5 years

First QC Date

September 11, 2024

Last Update Submit

September 18, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Survival Rate

    Survival Rate

    three years after treatment

  • Local Recurrence Rate

    Local Recurrence Rate

    three years after treatment

Secondary Outcomes (2)

  • DNA positive rate of Epstein-Barr(EB) virus

    three years after treatment

  • Body mass index

    three years after treatment

Study Arms (3)

group 1: Use AI to assist nutrition management

EXPERIMENTAL

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

group 2: Contact the nutritionist team of the hospital for nutrition management

EXPERIMENTAL

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 3: Do not adopt the two management methods.

NO INTERVENTION

blank control group

Interventions

group1:AI-assisted nutrition management. group 2:Traditional nutrition management(through the hospital dietitian).group 3:control.

group 1: Use AI to assist nutrition management

group 2:Traditional nutrition management(through the hospital dietitian)

group 2: Contact the nutritionist team of the hospital for nutrition management

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant tumor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Related Publications (5)

  • Kulkarni S, Seneviratne N, Baig MS, Khan AHA. Artificial Intelligence in Medicine: Where Are We Now? Acad Radiol. 2020 Jan;27(1):62-70. doi: 10.1016/j.acra.2019.10.001. Epub 2019 Oct 19.

    PMID: 31636002BACKGROUND
  • Mundi MS, Mohamed Elfadil O, Olson DA, Pattinson AK, Epp LM, Miller LD, Seegmiller SL, Schneckloth JM, Baker MR, Abdelmagid MG, Patel A, Wescott BA, Elder LS, Hagenbrock MC, Sefried LE, Hurt RT. Home enteral nutrition: A descriptive study. JPEN J Parenter Enteral Nutr. 2023 May;47(4):550-562. doi: 10.1002/jpen.2498. Epub 2023 Apr 12.

    PMID: 36912121BACKGROUND
  • Bischoff SC, Austin P, Boeykens K, Chourdakis M, Cuerda C, Jonkers-Schuitema C, Lichota M, Nyulasi I, Schneider SM, Stanga Z, Pironi L. ESPEN practical guideline: Home enteral nutrition. Clin Nutr. 2022 Feb;41(2):468-488. doi: 10.1016/j.clnu.2021.10.018. Epub 2021 Nov 24.

    PMID: 35007816BACKGROUND
  • Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.

    PMID: 33946039BACKGROUND
  • Liu J, Wang X, Ye X, Chen D. Improved health outcomes of nasopharyngeal carcinoma patients 3 years after treatment by the AI-assisted home enteral nutrition management. Front Nutr. 2025 Jan 7;11:1481073. doi: 10.3389/fnut.2024.1481073. eCollection 2024.

MeSH Terms

Conditions

NeoplasmsCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

January 1, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL

Locations