Long-term Vascular and Psychosocial Complications in Adolescent and Young Adult (AYA) Head and Neck Cancer Survivors.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Carotid wall thickness on MRI (mm)
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 23 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HNC patient treated with unilateral RT at age 18-40 years 5-10 years before
- •Informed Consent
Exclusion Criteria
- •Contra indication MRI
- •Able to communicate in Dutch language
Outcomes
Primary Outcomes
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
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
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
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
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)
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.
Secondary Outcomes
- Hospital Anxiety and Depression Scale (HADS).(5-10 years after radiotherapy)
- Fatigue severity(5-10 years after radiotherapy)
- Cognitive function(5-10 years after radiotherapy)
- Speech Handicap Index (SHI)(5-10 years after radiotherapy)
- Fear of recurrence(5-10 years after radiotherapy)
- Subjective Memory Complaints(5-10 years after radiotherapy)
- Quality of Life(5-10 years after radiotherapy)
- Brief symptoms Inventory (BSI)(5-10 years after radiotherapy)
- Cancer specific distress(5-10 years after radiotherapy)
