Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head-and-neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
| Neuro Psychological Assessment Battery | Diagnostic Test | — | UNRESOLVED |
| Questionaires | Diagnostic Test | — | UNRESOLVED |
| Ultrasonography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic intervention
- description
- Complete diagnostic intervention
- interventionNames
- Diagnostic Test: Ultrasonography
- Diagnostic Test: MRI
- Diagnostic Test: Neuro Psychological Assessment Battery
- Diagnostic Test: Questionaires
Primary outcomes (9)
- measure
- Intima Media Thickness (mm)
- timeFrame
- 5-10 years after radiotherapy
- description
- Intima Media thickness in mm on ultrasonography in the irradiated versus the non irradiated carotid artery
- measure
- Carotid wall elastography
- timeFrame
- 5-10 years after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 23 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPruijssen 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. PMID 35871069
- DERIVEDPruijssen 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. PMID 35248013