Cancer, CarcinomaNCT06603909
Health Outcomes of Nasopharyngeal Carcinoma Patients Three Years After Treatment by the AI-assisted Home Enteral Nutrition Management
A study testing group 1: Use AI to assist nutrition management and group 2：Traditional nutrition management（through the hospital dietitian） in people with Cancer, Carcinoma and Artificial Intelligence (AI), run by Changsha Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Carcinoma, Artificial Intelligence (AI), Nutrition
- What is being tested?
- group 1: Use AI to assist nutrition management and group 2：Traditional nutrition management（through the hospital dietitian）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Malignant tumor patient
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer, Carcinoma, Artificial Intelligence (AI), Nutrition
- Being tested
- group 1: Use AI to assist nutrition management, group 2：Traditional nutrition management（through the hospital dietitian）
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1: Use AI to assist nutrition managementOther
group1：AI-assisted nutrition management. group 2：Traditional nutrition management（through the hospital dietitian）.group 3:control.
group 2：Traditional nutrition management（through the hospital dietitian）Other
group 2：Traditional nutrition management（through the hospital dietitian）
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: group 2：Traditional nutrition management（through the hospital dietitian） |
| group 3: Do not adopt the two management methods. | No intervention | blank control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
Survival Rate
Measured: three years after treatment
Local Recurrence Rate
Local Recurrence Rate
Measured: three years after treatment
Secondary outcomes (2)
DNA positive rate of Epstein-Barr(EB) virus
DNA positive rate of Epstein-Barr(EB) virus
Measured: three years after treatment
Body mass index
Data was obtained through the intelligent body fat device
Measured: three years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer, CarcinomaStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changsha Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danna Chen, Changsha Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603909
- Sponsor's protocol ID
- AI-nutrition to NPC patients
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publish the paper publicly so that more people can learn about the results of the study
Publications
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.
PubMed 31636002Mundi 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.
PubMed 36912121Bischoff 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.
PubMed 35007816Muscaritoli 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.
PubMed 33946039Liu 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.
PubMed 39839291
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes of Nasopharyngeal Carcinoma Patients Three Years After Treatment by the AI-assisted Home Enteral Nutrition Management
- ClinicalTrials.gov ID
- NCT06603909
- Acronym / sponsor ID
- AI-nutrition to NPC patients
- Conditions
- Cancer, Carcinoma, Artificial Intelligence (AI), Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Changsha Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1: Use AI to assist nutrition management | Experimental | Other: group 1: Use AI to assist nutrition managementThe 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. |
| group 2: Contact the nutritionist team of the hospital for nutrition management | Experimental | Other: group 2：Traditional nutrition management（through the hospital dietitian）Contact the nutritionist team of the hospital for nutrition management according to patients' own situation |
| group 3: Do not adopt the two management methods. | No intervention | –blank control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Malignant tumor patient
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| group 1: Use AI to assist nutrition managementgroup1：AI-assisted nutrition management. group 2：Traditional nutrition management（through the hospital dietitian）.group 3:control. | Other | group 1: Use AI to assist nutrition management |
| group 2：Traditional nutrition management（through the hospital dietitian）group 2：Traditional nutrition management（through the hospital dietitian） | Other | group 2: Contact the nutritionist team of the hospital for nutrition management |
Primary outcome
Survival Rate
Time frame: three years after treatment
Survival Rate
Local Recurrence Rate
Time frame: three years after treatment
Local Recurrence Rate
2 secondary outcomes
DNA positive rate of Epstein-Barr(EB) virus
Time frame: three years after treatment
Body mass index
Time frame: three years after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 31636002Kulkarni 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.
- Results publication: PubMed 36912121Mundi 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.
- Results publication: PubMed 35007816Bischoff 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.
- Results publication: PubMed 33946039Muscaritoli 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.
- Derived from this study: PubMed 39839291Liu 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.
- Individual participant dataSharing planned: Yes. Publish the paper publicly so that more people can learn about the results of the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group 1: Use AI to assist nutrition management and group 2：Traditional nutrition management（through the hospital dietitian） in people with Cancer, Carcinoma and Artificial Intelligence (AI), run by Changsha Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate (time frame: three years after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06603909, which also lists 5 linked publications.
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 19 Sep 2024.