Head and Neck TumoursNCT02069964
A Prospective Longitudinal Cohort Study Looking at the Difference in Carotid Intima-medial Thickness Between Irradiated and Unirradiated Carotid Arteries in Patients With Head and Neck Cancer
An observational study of Head and Neck Tumours, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Some patients with head and neck cancer or benign tumours of the head and neck receive radiotherapy to their neck as part of their treatment. The large arteries in the neck, the carotid arteries, are often included in the area being treated with radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Tumours
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Oct 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with histologically confirmed canceror benign tumours of the head and neck area requiring hemi-neck radiotherapy to ≥ 50Gy
Who may be able to join
- Be 18 years or older
- Histologically confirmed cancer or benign tumours of the head and neck area requiring ≥ 50Gy to one side of the neck (conventional or intensity modulated RT)
- Prior or subsequent neck dissection allowed (irradiated and/or unirradiated side)
- Be able to provide written informed consent
Who cannot join
- Patients with bulky nodal neck disease that may interfere with acquisition of ultrasound images
- Patients with a prior history of carotid endarterectomy or carotid angioplasty and stenting
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
About this study
Some patients with head and neck cancer or benign tumours of the head and neck receive radiotherapy to their neck as part of their treatment. The large arteries in the neck, the carotid arteries, are often included in the area being treated with radiotherapy. There is some evidence to show that radiotherapy to these blood vessels can result in thickening and furring of the artery walls some years after treatment. This thickening may then result in stiffening and narrowing of the artery.
Current research is now aimed towards detecting radiotherapy-related changes to the carotid arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating these blood vessels if possible. The question of whether or not the use of preventive medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is currently unanswered.
Read more
The aim of this study is to compare the thickness (intima-medial thickness) of the carotid artery wall over time (a period of 5 years) following radiotherapy to the thickness in carotid arteries that have not received radiotherapy. There are many other causes for thickening of arteries (such as high blood pressure, high cholesterol levels and diabetes) and these may affect the ability to measure the effect of radiotherapy change to the artery wall. In order to address this, it is ideal to look at this process in patients who are having only one side of the neck treated and use the other side as a comparison. The study will also be investigating for earlier signs of radiotherapy-related changes, such as stiffening of the artery wall, inflammation in the artery wall (a very early sign of radiotherapy-related change) and some markers in the blood that may indicate that this process is taking place.
The null hypotheses of this study are:
- In irradiated carotid arteries, mean intimal-medial thickness at one year following radiotherapy will be the same as in unirradiated arteries.
- The incidence of carotid artery stenosis will be the same in irradiated and unirradiated carotid arteries
- Arterial wall strain at one year following radiotherapy will be the same in irradiated and unirradiated carotid arteries.
- Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries during radiotherapy as an early marker of atherosclerosis; microbubble ultrasound will not demonstrate at what dose of radiotherapy inflammation begins.
- Serum biomarker levels will not increase over time from baseline after radiotherapy and won't correlate to IMT and arterial strain.
- Conditions
- Head and Neck Tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective hemi-neck RT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean carotid IMT at one year after radiotherapy between irradiated and unirradiated carotid arteries.
Measured at baseline and 12 months after radiotherapy
Measured: 1 year
Secondary outcomes (7)
The difference in mean carotid IMT at 2 and 5 years after radiotherapy between irradiated and unirradiated carotid arteries.
Measured at baseline, weekly during radiotherapy, 3 and 6 months after radiotherapy, then annually to 5 years
Measured: 2 and 5 years
The incidence of carotid artery stenosis in irradiated carotid arteries compared to unirradiated carotid arteries.
Measured up to 5 years after radiotherapy
Measured: 5 years
The difference in carotid arterial wall strain following radiotherapy between irradiated and unirradiated carotid arteries.
Measured at baseline, weekly during radiotherapy, 3 and 6 months after radiotherapy, then annually to 5 years
Measured: 5 years
The difference in arterial wall inflammation between irradiated and unirradiated carotid arteries and dose-related effects
Measured at baseline, weekly during radiotherapy, 3 and 6 months after radiotherapy, then annually to 5 years
Measured: 5 years
The effect of risk-modifying therapy (anti-hypertensives, anti-diabetic medication, HMGCoA reductase inhibitors, smoking cessation) on irradiated and unirradiated carotid arteries.
Measured at baseline, 3 and 6 months after radiotherapy, then annually to 5 years
Measured: 5 years
The change in mean serum biomarker levels after radiotherapy.
Baseline, week 6 after radiotherapy, then 3-, 6-, and 12 months after radiotherapy
Measured: 1 year
The proportion of patients who develop stroke or TIA.
The proportion of patients who develop stroke or TIA during the trial period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startOct 2011
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumoursStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christopher M Nutting, PhD, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069964
- Sponsor's protocol ID
- CCR 3688
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Cohort Study Looking at the Difference in Carotid Intima-medial Thickness Between Irradiated and Unirradiated Carotid Arteries in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02069964
- Acronym / sponsor ID
- CCR 3688
- Conditions
- Head and Neck Tumours
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Oct 2011
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 24 Feb 2014 (estimated)
- 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.
Some patients with head and neck cancer or benign tumours of the head and neck receive radiotherapy to their neck as part of their treatment. The large arteries in the neck, the carotid arteries, are often included in the area being treated with radiotherapy. There is some evidence to show that radiotherapy to these blood vessels can result in thickening and furring of the artery walls some years after treatment. This thickening may then result in stiffening and narrowing of the artery.
Current research is now aimed towards detecting radiotherapy-related changes to the carotid arteries at an earlier stage and towards using new radiotherapy techniques to avoid treating these blood vessels if possible. The question of whether or not the use of preventive medicines like aspirin and cholesterol-lowering tablets helps to reverse this process is currently unanswered.
The aim of this study is to compare the thickness (intima-medial thickness) of the carotid artery wall over time (a period of 5 years) following radiotherapy to the thickness in carotid arteries that have not received radiotherapy. There are many other causes for thickening of arteries (such as high blood pressure, high cholesterol levels and diabetes) and these may affect the ability to measure the effect of radiotherapy change to the artery wall. In order to address this, it is ideal to look at this process in patients who are having only one side of the neck treated and use the other side as a comparison. The study will also be investigating for earlier signs of radiotherapy-related changes, such as stiffening of the artery wall, inflammation in the artery wall (a very early sign of radiotherapy-related change) and some markers in the blood that may indicate that this process is taking place.
The null hypotheses of this study are:
- In irradiated carotid arteries, mean intimal-medial thickness at one year following radiotherapy will be the same as in unirradiated arteries.
- The incidence of carotid artery stenosis will be the same in irradiated and unirradiated carotid arteries
- Arterial wall strain at one year following radiotherapy will be the same in irradiated and unirradiated carotid arteries.
- Microbubble ultrasound will not be able to detect Inflammation in the carotid arteries during radiotherapy as an early marker of atherosclerosis; microbubble ultrasound will not demonstrate at what dose of radiotherapy inflammation begins.
- Serum biomarker levels will not increase over time from baseline after radiotherapy and won't correlate to IMT and arterial strain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective hemi-neck RT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed canceror benign tumours of the head and neck area requiring hemi-neck radiotherapy to ≥ 50Gy
Key inclusion criteria (4 listed)
- Be 18 years or older
- Histologically confirmed cancer or benign tumours of the head and neck area requiring ≥ 50Gy to one side of the neck (conventional or intensity modulated RT)
- Prior or subsequent neck dissection allowed (irradiated and/or unirradiated side)
- Be able to provide written informed consent
Key exclusion criteria (2 listed)
- Patients with bulky nodal neck disease that may interfere with acquisition of ultrasound images
- Patients with a prior history of carotid endarterectomy or carotid angioplasty and stenting
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
The difference in mean carotid IMT at one year after radiotherapy between irradiated and unirradiated carotid arteries.
Time frame: 1 year
Measured at baseline and 12 months after radiotherapy
7 secondary outcomes
The difference in mean carotid IMT at 2 and 5 years after radiotherapy between irradiated and unirradiated carotid arteries.
Time frame: 2 and 5 years
The incidence of carotid artery stenosis in irradiated carotid arteries compared to unirradiated carotid arteries.
Time frame: 5 years
The difference in carotid arterial wall strain following radiotherapy between irradiated and unirradiated carotid arteries.
Time frame: 5 years
The difference in arterial wall inflammation between irradiated and unirradiated carotid arteries and dose-related effects
Time frame: 5 years
The effect of risk-modifying therapy (anti-hypertensives, anti-diabetic medication, HMGCoA reductase inhibitors, smoking cessation) on irradiated and unirradiated carotid arteries.
Time frame: 5 years
The change in mean serum biomarker levels after radiotherapy.
Time frame: 1 year
The proportion of patients who develop stroke or TIA.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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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.
Christopher M Nutting, PhD principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Tumours, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Feb 2014. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Starkings, MSc (00 44 207 811 8311, rachel.starkings@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in mean carotid IMT at one year after radiotherapy between irradiated and unirradiated carotid arteries. (time frame: 1 year). 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 24 Feb 2014.