Long Term Complications in Head and Neck Cancer Patients
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Postavení
Sponzoři
Radboud University
KLINICKÉ HODNOCENÍ: NCT04257968
BioSeek: nct04257968
Klíčová slova
Abstraktní
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.
Termíny
| Poslední ověření: | 09/30/2019 |
| První předloženo: | 10/16/2019 |
| Odhadovaná registrace vložena: | 02/04/2020 |
| První zveřejnění: | 02/05/2020 |
| Poslední aktualizace byla odeslána: | 02/04/2020 |
| Poslední aktualizace zveřejněna: | 02/05/2020 |
| Aktuální datum zahájení studie: | 01/21/2020 |
| Odhadované datum dokončení primární: | 11/30/2020 |
| Odhadované datum dokončení studie: | 11/30/2020 |
Stav nebo nemoc
Head-and-neck Cancer
Intervence / léčba
Diagnostic Test: Diagnostic intervention
Diagnostic Test: Diagnostic intervention
Diagnostic Test: Diagnostic intervention
Diagnostic Test: Diagnostic intervention
Fáze
-
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Experimental: Diagnostic intervention Complete diagnostic intervention | Diagnostic Test: Diagnostic intervention carotid ultrasonography (IMT and elastography) |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 23 Years Na 23 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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 |
Výsledek
Primární výsledná opatření
1. Intima Media Thickness (mm) [5-10 years after radiotherapy]
Intima Media thickness in mm on ultrasonography in the irradiated versus the non irradiated carotid artery
2. Carotid wall elastography [5-10 years after radiotherapy]
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)
3. Carotid wall thickness on MRI (mm) [5-10 years after radiotherapy]
Carotid wall thickness in mm on MRI in the irradiated versus the non-irradiated artery
4. Radiological characteristics of carotid wall changes on MRI [5-10 years after radiotherapy]
Radiological characteristics of carotid wall changes on MRI of the irradiated versus the non-irradiated artery: intensity on T1/T2/FLAIR/Proton Density.
5. Pack Years smoking [5-10 years after radiotherapy]
Pack Years smoking
6. Hypertension [5-10 years after radiotherapy]
Definition: Systolic Bloodpressure > 140 mmHg or taking antihypertensive medication
7. Cardiovascular risk management: Body Mass Index [5-10 years after radiotherapy]
weight and height will be combined to report BMI in kg/m^2
8. White matter hyperintensities on MRI [5-10 years after radiotherapy]
Volume of white matter hyperintensities on FLAIR in ml
9. Number of brain infarctions on MRI [5-10 years after radiotherapy]
Number of brain infarctions assessed on MRI
Měření sekundárních výsledků
1. Subjective Memory Complaints [5-10 years after radiotherapy]
Assessed by Cognitive Failure Questionairre:
a questionairre about failures in perception, attention, memory, and motor function.
29 items Total score Range 0-100
2. Cognitive function [5-10 years after radiotherapy]
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.
3. Hospital Anxiety and Depression Scale (HADS). [5-10 years after radiotherapy]
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
4. Fatigue severity [5-10 years after radiotherapy]
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. Speech Handicap Index (SHI) [5-10 years after radiotherapy]
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.
6. Brief symptoms Inventory (BSI) [5-10 years after radiotherapy]
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
7. Fear of recurrence [5-10 years after radiotherapy]
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.
8. Cancer specific distress [5-10 years after radiotherapy]
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).
9. Quality of Life [5-10 years after radiotherapy]
Assessed using the EORTC-QLQ-C30 questionairre consisting of 30 items. Total score: Range 0-100
