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Carotid Artery StenosisRT-CASinHNCNCT06556979

Carotid Artery Stenosis and Ischemic Cerebrovascular Events After Radiotherapy in Patients With Head and Neck Cancer

An observational study of Carotid Artery Stenosis and Head and Neck Cancer, run by Chulabhorn Royal Academy at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study had a cross-sectional design and included patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands who recieve RT. the investigators obtained information on their clinical and tumor characteristics and their treatment from the clinical records. Read more about this study

Who is it for?
Any age
What is being tested?
Radiotherapy
Type of treatment
Surgery or procedure
How many people
907 participants
Where
1 siteThailand
Study dates
1 Jan 2022to 1 Feb 2024
How long will I take part?
2 Years
Phase
Observational
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

Study population: patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands.

Who may be able to join

  • All patients underwent radiotherapy to the head and neck region between February 2011 and June 2022 with or without surgical resection and were investigated by computed tomography (CT) before and after radiotherapy.

Who cannot join

  • Patients with lymphoma and those with previous treatment for CAS or radiotherapy for other diseases were excluded.

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Department of Surgery, Chulabhorn Hospital, Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, Thailand

    Bangkok, 10210

Other trials in Thailand

About this study

The study had a cross-sectional design and included patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands who recieve RT.

the investigators obtained information on their clinical and tumor characteristics and their treatment from the clinical records. Data on risk factors for atherosclerosis, medications used, and radiotherapy were also collected.

Read more

Images were analyzed to determine the timing of development of CAS, identify significant (\>50%) CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria, and calculate the total plaque score (TPS) and wall thickness.

The purpose of this study was to determine the incidence of ICVE and of CAS in patients who receive radiotherapy for HNC and the risk factors for CAS.

Read the detailed description

The study had a cross-sectional design and included 907 patients with HNC involving the oral cavity, pharynx, larynx, nasal cavity, or salivary glands. The study was approved by the Chulabhorn Institutional Ethics Committee for Human Research (approval number 048/2565). All patients underwent radiotherapy to the head and neck region between February 2011 and June 2022 with or without surgical resection and were investigated by computed tomography (CT) before and after radiotherapy. Patients with lymphoma and those with previous treatment for CAS or radiotherapy for other diseases were excluded. We obtained information on patient background factors, tumor characteristics, and treatment from the medical records. Risk factors for atherosclerosis, including hypertension, dyslipidemia, diabetes mellitus, coronary artery disease, peripheral arterial disease, and cigarette smoking, were identified. Baseline laboratory data, including hemoglobin A1C, fasting blood sugar, lipid profile, serum creatinine level, and estimated glomerular filtration rate, were obtained, as was information on treatment, including antiplatelet agents, statins, angiotensin-converting enzyme inhibitors (ACEIs), calcium channel blockers (CCBs), and anticoagulants. The type and stage of HNC, indication for radiotherapy, type of radiotherapy, total cumulative dose, and number of courses were also recorded. Unfortunately, the laboratory data were incomplete in many cases, so could not be subjected to statistical analysis. Follow-up was continued until loss to follow-up, death, or the end of 2023, whichever came first. Moreover, full written informed consent was obtained from the patient for publication of this article. Confidentiality of the data was secured by assigning of a code for each patient record. Images were analyzed to determine the timing of development of CAS, identify significant (\>50%) CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria, and calculate the total plaque score (TPS) and wall thickness. The carotid vessels were divided into the common carotid artery (CCA), carotid bulb, internal carotid artery (ICA), and external carotid artery (ECA). The bulb was defined as the portion of the artery 1 cm caudally to 1 cm cranially from the point where the CCA divided into the ICA and ECA. The right and left carotid artery systems were each divided into the following five segments: proximal CCA (≥20 mm proximal to bulb), distal CCA (\<20 mm proximal to bulb), carotid bulb, ICA. and ECA. Each segment was graded as follows: 0, normal or no detectable plaque; 1, plaque occupying \<30% of vessel diameter; 2, plaque occupying 30%-49% of vessel diameter; 3, plaque occupying 50%-69% of vessel diameter; 4, plaque occupying 70%-99% of vessel diameter; and 5, 100% occlusion of vessel diameter by plaque. The carotid plaque score was obtained for each patient by summing the scores obtained for the five arterial segments in both carotid arteries. Wall thickness and degree of CAS were measured in the five segments of the carotid artery at baseline and during follow-up. Differences in these values were calculated. CT was performed at least twice. The initial CT scan was performed within 2 months before initiation of radiotherapy and follow-up CT was performed 1 month after completing radiotherapy. In cases with multiple follow-up CT scans, the last scan was used to evaluate post-radiation change. The 1-year follow-up CT scan was also examined. All baseline and follow-up measurements were made by a vascular surgeon who was blinded to the clinical data.

Being tested
Radiotherapy
Keywords
Carotid artery stenosis, Head and neck cancer, Radiation therapy, Transient ischemic attack, Ischemic stroke, Thailand
Medical subject headings
Carotid Stenosis, Head and Neck Neoplasms, Ischemic Attack, Transient, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    Review imaging and medical record of head and neck cancer patient who recieve radiotherpy to find out the incidence of ischemic cerebrovascular event and carotid artery stenosis. The risk factor that influence new carotid artery stenosis was claculated

Study groups in NCT06556979
Study groupRoleWhat they receive
HNC patient who recieve RTReviewing medical record of all patiented who receive radiotherapy and focusing in ischemic cerebrovascular event and carotid artery stenosis. We categorized the patiented to 3 group : no carotid artery stenosis, seen carotid artery stenosis and seen significant carotid artery stenosis and find the risk factor of preexisting carotid artery stenosis before RT
Receives: Radiation: Radiotherapy

What is being measured

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

  1. Incidence of ischemic cerebrovascular event after radiotherapy. (Percentage of partcipants who developed ischemic stroke or transient ischemic attack following completion of radiotherapy in all participants)

    The cumulative incidence of ischemic cerbrovascular event including ischemic stroke or transient ischemic attack in the anterior circulation in HNC patient who receive radiotherapy in 5 years

    Measured: 5 years

Secondary outcomes (2)
  1. The risk factors that were identified to influence development of new carotid artery stenosis

    The risk factors that were identified to influence development of new carotid artery stenosis from the first imaging to last imaging. The investigator assessed the number of patient who develop new carotid artery stenosis after radiotherapy. Carotid artery stenosis was measure by NASCET criteria : % ICA stenosis = (1 - [narrowest ICA diameter/diameter normal distal cervical ICA]) x 100

    Measured: through study completion, an average of 1 year

  2. Incidence of carotid artery stenosis at 12, 24, and 36 months after radiotherapy (Percentage of partcipants who develop carotid artery stenosis)

    The cumulative incidence of carotid artery stenosis was calculated after radiotherapy. The investigator assessed the number of patient who develop new carotid artery stenosis after radiotherapy. Carotid artery stenosis was measure by NASCET criteria : % ICA stenosis = (1 - [narrowest ICA diameter/diameter normal distal cervical ICA]) x 100

    Measured: 12, 24, 36 months

Timeline

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

  1. First posted16 Aug 2024
  2. Study start1 Jan 2022
  3. Primary completion1 Jan 2023
  4. Study completion1 Feb 2024

Resources

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
Cross-sectional
Enrolment
907 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556979
Sponsor's protocol ID
EC 048/2565
Acronym
RT-CASinHNC
Status last verified
Aug 2024
First submitted
8 Aug 2024
Last updated
16 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Stenosis and Head and Neck Cancer, run by Chulabhorn Royal Academy at 1 site in Thailand.

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 16 Aug 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 Thailand. 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?

Incidence of ischemic cerebrovascular event after radiotherapy. (Percentage of partcipants who developed ischemic stroke or transient ischemic attack following completion of radiotherapy in all participants) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Aug 2024.

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