NCT04257968

Long Term Complications in Head and Neck Cancer Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 23 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head-and-neck Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasonography	carotid ultrasonography (IMT and elastography)
DIAGNOSTIC_TEST	MRI	MRI of carotid artery and brain
DIAGNOSTIC_TEST	Neuro Psychological Assessment Battery	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
DIAGNOSTIC_TEST	Questionaires	Cognitive Failures, Depression, Anxiety, Fatigue, Speech handicap, fear for recurrence, Quality of Life.

Timeline

• Start date: 2020-01-22
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-02-06
• Last updated: 2020-02-06

Locations

1 site across 1 country: Netherlands