Long Term Complications in Head and Neck Cancer Patients

Head-and-neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04257968
• Other study ID #: NL71550.091.19
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head-and-neck Cancer

Intervention

Diagnostic Test:
• Ultrasonography
carotid ultrasonography (IMT and elastography)
• MRI
MRI of carotid artery and brain
• 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
• Questionaires
Cognitive Failures, Depression, Anxiety, Fatigue, Speech handicap, fear for recurrence, Quality of Life.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Pack Years smoking	Pack Years smoking	5-10 years after radiotherapy
Primary	Hypertension	Definition: Systolic Bloodpressure > 140 mmHg or taking antihypertensive medication	5-10 years after radiotherapy
Primary	Cardiovascular risk management: Body Mass Index	weight and height will be combined to report BMI in kg/m^2	5-10 years after radiotherapy
Primary	White matter hyperintensities on MRI	Volume of white matter hyperintensities on FLAIR in ml	5-10 years after radiotherapy
Primary	Number of brain infarctions on MRI	Number of brain infarctions assessed on MRI	5-10 years after radiotherapy
Secondary	Subjective Memory Complaints	Assessed by Cognitive Failure Questionairre: a questionairre about failures in perception, attention, memory, and motor function.; 29 items Total score Range 0-100	5-10 years after radiotherapy
Secondary	Cognitive function	Cognitive function per cognitive domain: Available normative data will be used to convert the patients results on the neuropsychological tests into standardized T scores (mean, SD), adjusted for age, sex and education.	5-10 years after radiotherapy
Secondary	Hospital Anxiety and Depression Scale (HADS).	Hospital Anxiety and Depression Scale (HADS). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.; 14 items Score depression: Range 0-21 Score Anxiety: Range 0-21 Total score: Range 0-42	5-10 years after radiotherapy
Secondary	Fatigue severity	Fatigue severity was assessed using the Checklist Individual Strength (CIS20R), a 20-item questionnaire that takes around five to ten minutes to fill out. Each question has a statement to be scored on a 7-point Likert scale ranging between 'yes, this is true' to 'no, this is not true'. The total score is calculated as the sum of the responses to the different statements. The maximum CIS20R score is 140, with a score of 76/140 or higher indicating that the patient is at risk for prolonged absence at work. The scale is subdivided in four dimensions of fatigue being fatigue severity (8 items, max. score 56), concentration problems (5 items, max. score 35), reduced motivation (4 items, max. score 28) and activity (3 items, max. score 21).; Total score: Range 20-140	5-10 years after radiotherapy
Secondary	Speech Handicap Index (SHI)	Assessed by Speech Handicap Index: a questionairre assessing self perceived speech function. 30 items A total SHI can be calculated ranging from 0-120, with higher scores indicating more speech problems and with a cutoff value of 6 being able to identify patients with speech problems in daily life.	5-10 years after radiotherapy
Secondary	Brief symptoms Inventory (BSI)	Assessed by Brief Symptom Inventory measure Brief Symptom Inventory (BSI) measure consists of 18 emotional distress items that are rated on a 5 point Likert scale and yield a Global Severity Index as well as Symptom Dimensions (Somatization, Depression, Anxiety.; Total score: Range 0-72	5-10 years after radiotherapy
Secondary	Fear of recurrence	Assessed by the Cancer Worry Scale (CWS): self reported 8-item scale, measuring worry about the risk of cancer recurrence and its impact on daily functioning. Total score ranges from 8 to 32. Higher scores indicate higher FCR. A cutoff score of 13 vs 14 (low FCR 13 or lower; high FCR 14 or more) has been established to differentiate between those with normal FCR from those with bothersome levels of FCR. This cutoff had been validated relative to the Fear of Cancer Recurrence Inventory cutoff score, which is a validated maesure.	5-10 years after radiotherapy
Secondary	Cancer specific distress	Assessed by Impact of Event Scale-Revised, which is a 22-items scale and includes subscales of intrusion, sleep disturbance, hyperarousal, avoidance and numbing. Items are scored on a 5-point scale, ranging from 0 (not at all) to 4 (extremely).	5-10 years after radiotherapy
Secondary	Quality of Life	Assessed using the EORTC-QLQ-C30 questionairre consisting of 30 items. Total score: Range 0-100	5-10 years after radiotherapy