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Clinical Trials/NCT04257968
NCT04257968UnknownNot Applicable

Long-term Vascular and Psychosocial Complications in Adolescent and Young Adult (AYA) Head and Neck Cancer Survivors.

Radboud University Medical Center1 site in 1 country40 target enrollmentStarted: January 22, 2020Last updated:
Conditions

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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