Clinical trial NCT04257968: Long Term Complications in Head and Neck Cancer Patients
Official title: Long-term Vascular and Psychosocial Complications in Adolescent and Young Adult (AYA) Head and Neck Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head-and-neck Cancer
Keywords: Head and Neck Cancer
Radiotherapy
Complications
Vascular
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 23
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intima Media Thickness (mm)
timeFrame: 5-10 years after radiotherapy
measure: Carotid wall elastography
timeFrame: 5-10 years after radiotherapy
measure: Carotid wall thickness on MRI (mm)
timeFrame: 5-10 years after radiotherapy
measure: Radiological characteristics of carotid wall changes on MRI
timeFrame: 5-10 years after radiotherapy
measure: Pack Years smoking
timeFrame: 5-10 years after radiotherapy
measure: Hypertension
timeFrame: 5-10 years after radiotherapy
measure: Cardiovascular risk management: Body Mass Index
timeFrame: 5-10 years after radiotherapy
measure: White matter hyperintensities on MRI
timeFrame: 5-10 years after radiotherapy
measure: Number of brain infarctions on MRI
timeFrame: 5-10 years after radiotherapy
Secondary outcomes:
measure: Subjective Memory Complaints
timeFrame: 5-10 years after radiotherapy
measure: Cognitive function
timeFrame: 5-10 years after radiotherapy
measure: Hospital Anxiety and Depression Scale (HADS).
timeFrame: 5-10 years after radiotherapy
measure: Fatigue severity
timeFrame: 5-10 years after radiotherapy
measure: Speech Handicap Index (SHI)
timeFrame: 5-10 years after radiotherapy
measure: Brief symptoms Inventory (BSI)
timeFrame: 5-10 years after radiotherapy
measure: Fear of recurrence
timeFrame: 5-10 years after radiotherapy
measure: Cancer specific distress
timeFrame: 5-10 years after radiotherapy
measure: Quality of Life
timeFrame: 5-10 years after radiotherapy
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Hans Kaanders, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pruijssen 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.