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

November 15, 2024 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
329

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Untreated newly diagnosed nasopharyngeal carcinoma patients without metastasis.

Description

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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;
  • 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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The relationship between hippocampal atrophy, radiation dose, and cognitive function after radiotherapy.
Time Frame: 2 years
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.
2 years
The relationship between hippocampal functional impairment, radiation dose, and cognitive function after radiotherapy.
Time Frame: 2 years
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.
2 years
The relationship between hippocampal microstructural damage, radiation dose, and cognitive function after radiotherapy.
Time Frame: 2 years
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.
2 years
The relationship between hippocampal microvascular injury, radiation dose, and cognitive function after radiotherapy.
Time Frame: 2 years
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.
2 years
The impact of different chemoradiation treatment modalities on the occurrence of cognitive decline.
Time Frame: 2 years
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.
2 years
The correlation between cognitive decline after radiotherapy and quality of life.
Time Frame: 2 years
"The quality of life will be prospectively assessed before treatment and followed up continuously after radiotherapy."
2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-FXY-132

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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