Head-and-neck CancerNCT04257968
Long Term Complications in Head and Neck Cancer Patients
A study testing Ultrasonography, MRI and Neuro Psychological Assessment Battery in people with Head-and-neck Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Problem: With increasing numbers of cancer survivors, strategies to prevent long-term complications in cancer patients become more important. Adolescent and Young Adult (AYA) Head and Neck Cancer survivors treated with radiotheray (RT) are prone to long-term complications, especially vascular and psychosocial… Read more about this study
- Who is it for?
- Ages 23 to 50 years
- Conditions the study is for
- Head-and-neck Cancer
- What is being tested?
- Ultrasonography, MRI and Neuro Psychological Assessment Battery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2020to Dec 2020
- 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 23 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HNC patient treated with unilateral RT at age 18-40 years 5-10 years before
- Informed Consent
Who cannot join
- Contra indication MRI
- Able to communicate in Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Vascular and Psychosocial Complications in Adolescent and Young Adult (AYA) Head and Neck Cancer Survivors.
Problem:
With increasing numbers of cancer survivors, strategies to prevent long-term complications in cancer patients become more important. Adolescent and Young Adult (AYA) Head and Neck Cancer survivors treated with radiotheray (RT) are prone to long-term complications, especially vascular and psychosocial complications. Although several studies point to the importance of these long-term complications, structured survivorship care for AYA HNC survivors is still lacking.
Read more
Primary objective:
To investigate in AYA HNC survivors treated with unilateral RT at least 5 years before, the long-term vascular complications in terms of carotid wall changes (ultrasonography, MRI), cerebral vascular complications ((silent)brain infarctions, white matter lesions) and Cardiovascular Risk Management profile.
Secondary objective:
To investigate in AYA HNC survivors treated with unilateral RT at least 5 years before, the long-term psychosocial complications (subjective memory complaints, Depression, Anxiety, Fatigue, Speach handicap, Anxiety for recurrence, Quality of Life, objective cognitive failure)
Study design Prospective cohort study.
Patient population AYA HNC survivors ≥ 5 years after unilateral RT, either alone or in combination with surgery and/or chemotherapy.
Controls The ultrasonography (Intima Media Thickness, elastography) and MRI measurements of the irradiated carotid wall will be compared to the non-irradiated carotid wall. Cognitive performance will be compared to normative data. The cognitive performances of the right hemisphere tests will be compared to the cognitive performances of the left hemisphere tests. The frequency of silent brain infarcts and vascular white matter lesions of the irradiated vascular territory will be compared with the non-irradiated territory.
Intervention Structured survivorship care ≥ 5 years after RT conform the Personalized Cancer Survivorship Care Model of the Radboudumc Expertisecenter of late effects after cancer, complemented with carotid ultrasonography (IMT and elastography), MRI of the carotid arteries and brain), neuropsychological assessment battery and self-reported questionnaires concerning depression, fatigue, QoL, positive health and employment status.
- Conditions
- Head-and-neck Cancer
- Being tested
- Ultrasonography, MRI, Neuro Psychological Assessment Battery, Questionaires
- Keywords
- Head and Neck Cancer, Radiotherapy, Complications, Vascular
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
carotid ultrasonography (IMT and elastography)
MRIDiagnostic test
MRI of carotid artery and brain
Neuro Psychological Assessment BatteryDiagnostic test
Hopkins Verbal Learning Test Digit Span WAIS-IV Stroop Color Word test Trail Making Test Brixton Spatial Anticipation Test Fluency letter (B-D-H) Fluency animal naming Symbol Digit Substitution WAIS-IV
QuestionairesDiagnostic test
Cognitive Failures, Depression, Anxiety, Fatigue, Speech handicap, fear for recurrence, Quality of Life.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic intervention | Experimental | Complete diagnostic intervention Receives: Diagnostic Test: Ultrasonography; Diagnostic Test: MRI; Diagnostic Test: Neuro Psychological Assessment Battery; Diagnostic Test: Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima Media Thickness (mm)
Intima Media thickness in mm on ultrasonography in the irradiated versus the non irradiated carotid artery
Measured: 5-10 years after radiotherapy
Carotid wall elastography
Carotid wall elastography on ultrasonography in the irradiated versus the non-irradiated artery:
distense coëfficiënt, pulse wave velocity (PWV) (during diastole and systole) and shear wave velocity (SWV) (2-8 moments during heartbeat)
Measured: 5-10 years after radiotherapy
Carotid wall thickness on MRI (mm)
Carotid wall thickness in mm on MRI in the irradiated versus the non-irradiated artery
Measured: 5-10 years after radiotherapy
Radiological characteristics of carotid wall changes on MRI
Radiological characteristics of carotid wall changes on MRI of the irradiated versus the non-irradiated artery: intensity on T1/T2/FLAIR/Proton Density.
Measured: 5-10 years after radiotherapy
Pack Years smoking
Pack Years smoking
Measured: 5-10 years after radiotherapy
Hypertension
Definition: Systolic Bloodpressure > 140 mmHg or taking antihypertensive medication
Measured: 5-10 years after radiotherapy
Cardiovascular risk management: Body Mass Index
weight and height will be combined to report BMI in kg/m^2
Measured: 5-10 years after radiotherapy
White matter hyperintensities on MRI
Volume of white matter hyperintensities on FLAIR in ml
Measured: 5-10 years after radiotherapy
Number of brain infarctions on MRI
Number of brain infarctions assessed on MRI
Measured: 5-10 years after radiotherapy
Secondary outcomes (9)
Subjective Memory Complaints
Assessed by Cognitive Failure Questionairre:
a questionairre about failures in perception, attention, memory, and motor function.
29 items Total score Range 0-100
Measured: 5-10 years after radiotherapy
Cognitive function
Cognitive function per cognitive domain:
Available normative data will be used to convert the patients results on the neuropsychological tests into standardized T scores (mean, SD), adjusted for age, sex and education.
Measured: 5-10 years after radiotherapy
Hospital Anxiety and Depression Scale (HADS).
Hospital Anxiety and Depression Scale (HADS). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.
14 items Score depression: Range 0-21 Score Anxiety: Range 0-21 Total score: Range 0-42
Measured: 5-10 years after radiotherapy
Fatigue severity
Fatigue severity was assessed using the Checklist Individual Strength (CIS20R), a 20-item questionnaire that takes around five to ten minutes to fill out. Each question has a statement to be scored on a 7-point Likert scale ranging between 'yes, this is true' to 'no, this is not true'. The total score is calculated as the sum of the responses to the different statements. The maximum CIS20R score is 140, with a score of 76/140 or higher indicating that the patient is at risk for prolonged absence at work. The scale is subdivided in four dimensions of fatigue being fatigue severity (8 items, max. score 56), concentration problems (5 items, max. score 35), reduced motivation (4 items, max. score 28) and activity (3 items, max. score 21).
Total score: Range 20-140
Measured: 5-10 years after radiotherapy
Speech Handicap Index (SHI)
Assessed by Speech Handicap Index:
a questionairre assessing self perceived speech function. 30 items A total SHI can be calculated ranging from 0-120, with higher scores indicating more speech problems and with a cutoff value of 6 being able to identify patients with speech problems in daily life.
Measured: 5-10 years after radiotherapy
Brief symptoms Inventory (BSI)
Assessed by Brief Symptom Inventory measure Brief Symptom Inventory (BSI) measure consists of 18 emotional distress items that are rated on a 5 point Likert scale and yield a Global Severity Index as well as Symptom Dimensions (Somatization, Depression, Anxiety.
Total score: Range 0-72
Measured: 5-10 years after radiotherapy
Fear of recurrence
Assessed by the Cancer Worry Scale (CWS):
self reported 8-item scale, measuring worry about the risk of cancer recurrence and its impact on daily functioning. Total score ranges from 8 to 32. Higher scores indicate higher FCR. A cutoff score of 13 vs 14 (low FCR 13 or lower; high FCR 14 or more) has been established to differentiate between those with normal FCR from those with bothersome levels of FCR. This cutoff had been validated relative to the Fear of Cancer Recurrence Inventory cutoff score, which is a validated maesure.
Measured: 5-10 years after radiotherapy
Cancer specific distress
Assessed by Impact of Event Scale-Revised, which is a 22-items scale and includes subscales of intrusion, sleep disturbance, hyperarousal, avoidance and numbing. Items are scored on a 5-point scale, ranging from 0 (not at all) to 4 (extremely).
Measured: 5-10 years after radiotherapy
Quality of Life
Assessed using the EORTC-QLQ-C30 questionairre consisting of 30 items. Total score: Range 0-100
Measured: 5-10 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start22 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head-and-neck CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Kaanders, MD, PhD, Prof, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257968
- Sponsor's protocol ID
- NL71550.091.19
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pruijssen JT, Wilbers J, Meijer FJA, Pegge SAH, Loonen JJ, de Korte CL, Kaanders JHAM, Hansen HHG. Assessing radiation-induced carotid vasculopathy using ultrasound after unilateral irradiation: a cross-sectional study. Radiat Oncol. 2022 Jul 23;17(1):130. doi: 10.1186/s13014-022-02101-7.
PubMed 35871069Pruijssen JT, Wenmakers A, Kessels RPC, Piai V, Meijer FJA, Pegge SAH, Loonen JJ, Tuladhar AM, Hansen HHG, Kaanders JHAM, Wilbers J. Long-term cognitive, psychosocial, and neurovascular complications of unilateral head and neck irradiation in young to middle-aged adults. BMC Cancer. 2022 Mar 5;22(1):244. doi: 10.1186/s12885-022-09295-9.
PubMed 35248013
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Vascular and Psychosocial Complications in Adolescent and Young Adult (AYA) Head and Neck Cancer Survivors.
- ClinicalTrials.gov ID
- NCT04257968
- Acronym / sponsor ID
- NL71550.091.19
- Conditions
- Head-and-neck Cancer
- Keywords
- Head and Neck Cancer, Radiotherapy, Complications, Vascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Feb 2020 (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.
Problem:
With increasing numbers of cancer survivors, strategies to prevent long-term complications in cancer patients become more important. Adolescent and Young Adult (AYA) Head and Neck Cancer survivors treated with radiotheray (RT) are prone to long-term complications, especially vascular and psychosocial complications. Although several studies point to the importance of these long-term complications, structured survivorship care for AYA HNC survivors is still lacking.
Primary objective:
To investigate in AYA HNC survivors treated with unilateral RT at least 5 years before, the long-term vascular complications in terms of carotid wall changes (ultrasonography, MRI), cerebral vascular complications ((silent)brain infarctions, white matter lesions) and Cardiovascular Risk Management profile.
Secondary objective:
To investigate in AYA HNC survivors treated with unilateral RT at least 5 years before, the long-term psychosocial complications (subjective memory complaints, Depression, Anxiety, Fatigue, Speach handicap, Anxiety for recurrence, Quality of Life, objective cognitive failure)
Study design Prospective cohort study.
Patient population AYA HNC survivors ≥ 5 years after unilateral RT, either alone or in combination with surgery and/or chemotherapy.
Controls The ultrasonography (Intima Media Thickness, elastography) and MRI measurements of the irradiated carotid wall will be compared to the non-irradiated carotid wall. Cognitive performance will be compared to normative data. The cognitive performances of the right hemisphere tests will be compared to the cognitive performances of the left hemisphere tests. The frequency of silent brain infarcts and vascular white matter lesions of the irradiated vascular territory will be compared with the non-irradiated territory.
Intervention Structured survivorship care ≥ 5 years after RT conform the Personalized Cancer Survivorship Care Model of the Radboudumc Expertisecenter of late effects after cancer, complemented with carotid ultrasonography (IMT and elastography), MRI of the carotid arteries and brain), neuropsychological assessment battery and self-reported questionnaires concerning depression, fatigue, QoL, positive health and employment status.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic intervention | Experimental | Diagnostic Test: Ultrasonography, Diagnostic Test: MRI, Diagnostic Test: Neuro Psychological Assessment Battery, Diagnostic Test: QuestionairesComplete diagnostic intervention |
Who may qualify
- Ages
- 23 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- HNC patient treated with unilateral RT at age 18-40 years 5-10 years before
- Informed Consent
Key exclusion criteria (2 listed)
- Contra indication MRI
- Able to communicate in Dutch language
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 |
|---|---|---|
| Ultrasonographycarotid ultrasonography (IMT and elastography) | Diagnostic test | Diagnostic intervention |
| MRIMRI of carotid artery and brain | Diagnostic test | Diagnostic intervention |
| Neuro Psychological Assessment BatteryHopkins Verbal Learning Test Digit Span WAIS-IV Stroop Color Word test Trail Making Test Brixton Spatial Anticipation Test Fluency letter (B-D-H) Fluency animal naming Symbol Digit Substitution WAIS-IV | Diagnostic test | Diagnostic intervention |
| QuestionairesCognitive Failures, Depression, Anxiety, Fatigue, Speech handicap, fear for recurrence, Quality of Life. | Diagnostic test | Diagnostic intervention |
Primary outcome
Intima Media Thickness (mm)
Time frame: 5-10 years after radiotherapy
Intima Media thickness in mm on ultrasonography in the irradiated versus the non irradiated carotid artery
Carotid wall elastography
Time frame: 5-10 years after radiotherapy
Carotid wall elastography on ultrasonography in the irradiated versus the non-irradiated artery: distense coëfficiënt, pulse wave velocity (PWV) (during diastole and systole) and shear wave velocity (SWV) (2-8 moments during heartbeat)
Carotid wall thickness on MRI (mm)
Time frame: 5-10 years after radiotherapy
Carotid wall thickness in mm on MRI in the irradiated versus the non-irradiated artery
Radiological characteristics of carotid wall changes on MRI
Time frame: 5-10 years after radiotherapy
Radiological characteristics of carotid wall changes on MRI of the irradiated versus the non-irradiated artery: intensity on T1/T2/FLAIR/Proton Density.
Pack Years smoking
Time frame: 5-10 years after radiotherapy
Pack Years smoking
Hypertension
Time frame: 5-10 years after radiotherapy
Definition: Systolic Bloodpressure > 140 mmHg or taking antihypertensive medication
Cardiovascular risk management: Body Mass Index
Time frame: 5-10 years after radiotherapy
weight and height will be combined to report BMI in kg/m^2
White matter hyperintensities on MRI
Time frame: 5-10 years after radiotherapy
Volume of white matter hyperintensities on FLAIR in ml
Number of brain infarctions on MRI
Time frame: 5-10 years after radiotherapy
Number of brain infarctions assessed on MRI
9 secondary outcomes
Subjective Memory Complaints
Time frame: 5-10 years after radiotherapy
Cognitive function
Time frame: 5-10 years after radiotherapy
Hospital Anxiety and Depression Scale (HADS).
Time frame: 5-10 years after radiotherapy
Fatigue severity
Time frame: 5-10 years after radiotherapy
Speech Handicap Index (SHI)
Time frame: 5-10 years after radiotherapy
Brief symptoms Inventory (BSI)
Time frame: 5-10 years after radiotherapy
Fear of recurrence
Time frame: 5-10 years after radiotherapy
Cancer specific distress
Time frame: 5-10 years after radiotherapy
Quality of Life
Time frame: 5-10 years after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 35871069Pruijssen JT, Wilbers J, Meijer FJA, Pegge SAH, Loonen JJ, de Korte CL, Kaanders JHAM, Hansen HHG. Assessing radiation-induced carotid vasculopathy using ultrasound after unilateral irradiation: a cross-sectional study. Radiat Oncol. 2022 Jul 23;17(1):130. doi: 10.1186/s13014-022-02101-7.
- Derived from this study: PubMed 35248013Pruijssen JT, Wenmakers A, Kessels RPC, Piai V, Meijer FJA, Pegge SAH, Loonen JJ, Tuladhar AM, Hansen HHG, Kaanders JHAM, Wilbers J. Long-term cognitive, psychosocial, and neurovascular complications of unilateral head and neck irradiation in young to middle-aged adults. BMC Cancer. 2022 Mar 5;22(1):244. doi: 10.1186/s12885-022-09295-9.
- Individual participant dataSharing planned: No
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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.
Hans Kaanders, MD, PhD, Prof principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography, MRI and Neuro Psychological Assessment Battery in people with Head-and-neck Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 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 6 Feb 2020. 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 Netherlands. 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?
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?
Intima Media Thickness (mm) (time frame: 5-10 years after radiotherapy). The study lists 9 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 NCT04257968, which also lists 2 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 6 Feb 2020.