Nasopharyngeal Carcinoma (NPC)NCT06695936

Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study

An observational study of Nasopharyngeal Carcinoma (NPC) and Cognitive Function, run by Sun Yat-sen University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This is an observational cohort study aimed at investigating changes in hippocampal function and its impact on cognitive function in newly diagnosed nasopharyngeal carcinoma patients without metastasis, from baseline to a period after radiotherapy. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Nasopharyngeal Carcinoma (NPC), Cognitive Function
How many people: 329 participants
Where: No sites listed yet
Study dates: 15 Nov 2024to 20 Nov 2028
How long will I take part?: 2 Years
Phase: Observational
Are there results?: Not yet: the study is under way

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 18 to 60 years
All sexes
No healthy volunteers
Adult

Study population: Untreated newly diagnosed nasopharyngeal carcinoma patients without metastasis.

Who may be able to join

Newly diagnosed nasopharyngeal carcinoma patients confirmed by pathology, who have not received surgical, induction chemotherapy, radiotherapy, or other anti-tumor treatments;
Clinical stage classified as AJCC 8th edition Stage I-IVa, with no distant metastasis, and who are scheduled to undergo intensity-modulated radiotherapy (IMRT) according to clinical plans;
Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III);
All participants are Han Chinese and right-handed;
Age between 18 and 60 years, with an education level of junior high school or above;
No history of neurological diseases or head trauma;

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No other severe systemic diseases other than nasopharyngeal carcinoma;
No hippocampal invasion before treatment;
Routine MRI before treatment shows no abnormal lesions in the hippocampus;
No family history of mental illness.

Who cannot join

Routine MRI before treatment shows abnormal lesions in the hippocampus;
Contraindications for magnetic resonance examination;
Concurrent other brain diseases;
Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO type I);
Patients with recurrence or distant metastasis;
Patients who have previously undergone radiotherapy or chemotherapy;

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Abnormal function of vital organs such as heart, brain, or lungs;
History of head trauma or mental/neuro diseases;
Age less than 18 years or greater than 60 years;
Patients whose initial treatment plan is changed during the observation
period due to disease progression (including residual tumors after
radiotherapy, tumor recurrence, or newly developed distant metastasis);
Patients with diabetes or hypertension;
Those unable to cooperate in completing neurocognitive scale testing;
Those with other uncontrolled severe diseases.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Haiqiang Mai, Dr contact

86-20-8734-3643

maihq@mail.sysu.edu.cn

About this study

Conditions: Nasopharyngeal Carcinoma (NPC), Cognitive Function
Medical subject headings: Nasopharyngeal Carcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of cognitive decline.
In a cohort of nasopharyngeal carcinoma patients undergoing intensity-modulated radiotherapy, we will observe the incidence of cognitive decline from baseline, at the end of radiotherapy, and post-treatment. The study will investigate the impact of hippocampal radiation dose on cognitive function in these patients and summarize the patterns of change.
Measured: 2 years

Secondary outcomes (6)

The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.
Statistical analysis will be conducted based on the changes in hippocampal volume before and after radiotherapy, tumor target dose, hippocampal irradiation dose, and cognitive function scale test results.
Measured: 2 years
The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.
Using resting-state fMRI technology, individual local brain function and default network information will be obtained. Variance analysis will be used to compare hippocampal changes before and after radiotherapy, clarifying the relationship between hippocampal functional damage, radiation dose, and cognitive function post-radiotherapy.
Measured: 2 years
The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.
Using Synthetic MRI imaging technology, imaging data of nasopharyngeal carcinoma patients will be collected before and after radiotherapy to provide individual whole-brain quantitative parameters and hippocampal microstructural information. Variance analysis will be used to compare pre- and post-radiotherapy differences, elucidating the relationship between hippocampal microstructural damage, radiation dose, and cognitive function.
Measured: 2 years
The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.
Based on multimodal MRI technology, this study will explore the microvascular status and changes in blood perfusion in nasopharyngeal carcinoma patients before and after radiotherapy, clarifying the relationship between hippocampal microvascular damage, radiation dose, and cognitive function post-radiotherapy.
Measured: 2 years
The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.
According to the TPS planning system dose statistics and dose-volume histogram, we will quantify the irradiation dose-volume of critical organs, including: hippocampal volume, tumor target volume, clinical target volume, and planning target volume; maximum dose and average dose of the hippocampus, as well as parameters on the dose-volume histogram. The cognitive function of patients after radiotherapy will be evaluated based on common adverse events as defined by CTCAE.
Measured: 2 years
The correlation between cognitive decline after radiotherapy and quality of life.
"The quality of life will be prospectively assessed before treatment and followed up continuously after radiotherapy."
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 202420 Nov 2028

First posted19 Nov 2024
Study start15 Nov 2024 (estimated)
Primary completion15 Nov 2028 (estimated)
Study completion20 Nov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 329 participants (estimated)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06695936
Sponsor's protocol ID: 2024-FXY-132
Status last verified: Oct 2024
First submitted: 15 Nov 2024
Last updated: 19 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Haiqiang Mai, Dr

86-20-8734-3643

maihq@mail.sysu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma

All Nasopharyngeal Carcinoma (NPC) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment with Intensity Modulated Radiotherapy on the Change of Cognitive Function in Nasopharyngeal Carcinoma Patients: a Prospective Cohort Study
ClinicalTrials.gov ID: NCT06695936
Acronym / sponsor ID: 2024-FXY-132
Conditions: Nasopharyngeal Carcinoma (NPC), Cognitive Function
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 329 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 15 Nov 2024 (estimated)
Primary completion: 15 Nov 2028 (estimated)
Study completion: 20 Nov 2028 (estimated)
First posted: 19 Nov 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 2 Years

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Untreated newly diagnosed nasopharyngeal carcinoma patients without metastasis.

Key inclusion criteria (10 listed)

Newly diagnosed nasopharyngeal carcinoma patients confirmed by pathology, who have not received surgical, induction chemotherapy, radiotherapy, or other anti-tumor treatments;
Clinical stage classified as AJCC 8th edition Stage I-IVa, with no distant metastasis, and who are scheduled to undergo intensity-modulated radiotherapy (IMRT) according to clinical plans;
Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III);
All participants are Han Chinese and right-handed;
Age between 18 and 60 years, with an education level of junior high school or above;

Key exclusion criteria (15 listed)

Routine MRI before treatment shows abnormal lesions in the hippocampus;
Contraindications for magnetic resonance examination;
Concurrent other brain diseases;
Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO type I);
Patients with recurrence or distant metastasis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Incidence of cognitive decline.
Time frame: 2 years
In a cohort of nasopharyngeal carcinoma patients undergoing intensity-modulated radiotherapy, we will observe the incidence of cognitive decline from baseline, at the end of radiotherapy, and post-treatment. The study will investigate the impact of hippocampal radiation dose on cognitive function in these patients and summarize the patterns of change.

6 secondary outcomes

The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.
Time frame: 2 years
The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.
Time frame: 2 years
The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.
Time frame: 2 years
The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.
Time frame: 2 years
The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.
Time frame: 2 years
The correlation between cognitive decline after radiotherapy and quality of life.
Time frame: 2 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.

Related trials for Nasopharyngeal Carcinoma (NPC)

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma

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.

Haiqiang Mai, Dr contact

86-20-8734-3643

maihq@mail.sysu.edu.cn

Questions about this trial

What is this clinical trial studying?

An observational study of Nasopharyngeal Carcinoma (NPC) and Cognitive Function, run by Sun Yat-sen University.

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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haiqiang Mai, Dr (86-20-8734-3643, maihq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of cognitive decline. (time frame: 2 years). 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 NCT06695936.

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 Nov 2024.