Long Term Complications in Head and Neck Cancer Patients

NCT04257968 | Unknown DMC

• 1 other identifier: NL71550.091.19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head-and-neck Cancer

Keywords

Head and Neck Cancer; Radiotherapy; Complications; Vascular

Outcome Measures

Primary Outcomes (9)

• Intima Media Thickness (mm)

  Intima Media thickness in mm on ultrasonography in the irradiated versus the non irradiated carotid artery

  5-10 years after radiotherapy

• Carotid wall elastography

  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)

  5-10 years after radiotherapy

• Carotid wall thickness on MRI (mm)

  Carotid wall thickness in mm on MRI in the irradiated versus the non-irradiated artery

  5-10 years after radiotherapy

• Radiological characteristics of carotid wall changes on MRI

  Radiological characteristics of carotid wall changes on MRI of the irradiated versus the non-irradiated artery: intensity on T1/T2/FLAIR/Proton Density.

  5-10 years after radiotherapy

• Pack Years smoking

  Pack Years smoking

  5-10 years after radiotherapy

• Hypertension

  Definition: Systolic Bloodpressure \> 140 mmHg or taking antihypertensive medication

  5-10 years after radiotherapy

• Cardiovascular risk management: Body Mass Index

  weight and height will be combined to report BMI in kg/m\^2

  5-10 years after radiotherapy

• White matter hyperintensities on MRI

  Volume of white matter hyperintensities on FLAIR in ml

  5-10 years after radiotherapy

• Number of brain infarctions on MRI

  Number of brain infarctions assessed on MRI

  5-10 years after radiotherapy

Secondary Outcomes (9)

• Subjective Memory Complaints

  5-10 years after radiotherapy

• Cognitive function

  5-10 years after radiotherapy

• Hospital Anxiety and Depression Scale (HADS).

  5-10 years after radiotherapy

• Fatigue severity

  5-10 years after radiotherapy

• Speech Handicap Index (SHI)

  5-10 years after radiotherapy

Study Arms (1)

Diagnostic intervention

EXPERIMENTAL

Complete diagnostic intervention

Diagnostic Test: Ultrasonography; Diagnostic Test: MRI; Diagnostic Test: Neuro Psychological Assessment Battery; Diagnostic Test: Questionaires

Interventions

Ultrasonography DIAGNOSTIC_TEST

carotid ultrasonography (IMT and elastography)

Diagnostic intervention

MRI DIAGNOSTIC_TEST

MRI of carotid artery and brain

Diagnostic intervention

Neuro Psychological Assessment Battery DIAGNOSTIC_TEST

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 intervention

Questionaires DIAGNOSTIC_TEST

Cognitive Failures, Depression, Anxiety, Fatigue, Speech handicap, fear for recurrence, Quality of Life.

Diagnostic intervention

Eligibility Criteria

• Age: 23 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HNC patient treated with unilateral RT at age 18-40 years 5-10 years before
• Informed Consent

You may not qualify if:

• Contra indication MRI
• Able to communicate in Dutch language

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 35871069 DERIVED

• 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.

  PMID: 35248013 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hans Kaanders, MD, PhD, Prof

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: February 6, 2020
• Study Start: January 22, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 6, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)