Cerebral Morbidity After Radiation Therapy for Brain Tumors

Cognitive Impairment Clinical Trial

— WP-12  

Official title:

Cerebral Morbidity After Radiation Therapy for Brain Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04292353
• Other study ID #: WP-12
• Status: Active, not recruiting
• Start date: July 1, 2016
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.

Description:

RT to brain tumours causes cognitive dysfunction. The extent of RT induced changes in cognitive function and radio-sensitivity of the brain is unknown. RT with protons instead of photons spares the healthy brain tissue more and is believed to reduce the risk of cognitive dysfunction. There is modest knowledge on which parts of the brain we need to spare, to prevent cognitive dysfunction.

The study is a prospective nationwide study including approximately 60 brain tumour patients from the four neuro oncology centres in Denmark. The patients will do patient reported outcome (PRO) and undergo neuropsychological assessment with standardized tests: They will do this prior to RT treatment and ½, 1, 3 and 5 years afterwards. The PRO's included measures on quality of life, fatigue, sleep, depression, anxiety, and socio demografica. The standardized tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV; Paced Auditory Serial Addition Test (PASAT). The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.

This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 years or older and Danish speaking.

• Performance status WHO 0-2

• Capable of cooperating on testing

• Tumor histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligidendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas

Exclusion Criteria:

• Glioblastoma

• Performance status 3-4

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Cognitive Impairment
• Radiation Toxicity

Intervention

Other:
• Cognitive tests and Patient Reported Outcome

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region Nord
Denmark	Department of Oncology	Aarhus	Region Midt
Denmark	Rigshospital	Copenhagen	Region H
Denmark	Odense University Hospital	Odense	Region Syd

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impairment of memory as assessed by the HVLT-r test	Examined by the Hopkins Verbal Learning Test. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)	5 Years
Secondary	Processing speed	Examined by the Trail making Test part A (TMT_A) and the Coding from WAIS-IV. Outcome for TMT_A is time in seconds (0-120 seconds). Outcome for Coding is number of correct (within 2 minutes) (0-100)	5 Years
Secondary	Attention and working memory	Examined by WAIS_IV_digit_span and PASAT (Pased Auditory Seriel Addition Test). Outcome on WAIS digit span is number of correct (0-36) and outcome for PASAT is number of incorrects (0-60)	5 Years
Secondary	Verbal learning and memory	Examine by the Hopkins Verbal Learning Test (HVLT) - total and delayed. Outcome is number of correct words (0-24)	5 Years
Secondary	Verbal fluency	Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter_S. Outcome is number of words produced in 1 minute (0-100)	5 Years
Secondary	Executive function	Examined by Trail making Test part B (TMT-B) and the STROOP colour and word test (STROOP). Outcome for TMT_B is time in seconds (0-300). Outcome for STROOP is number of corrects (0-120)	5 Years
Secondary	Global Health - Quality of life	Assessed by questionnaire; EORTC QlQ-C30 in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. Quality of life will be assessed by EORTC QIQ-C-30	5 Years
Secondary	Fatigue	Assessed by questionnaire: FACIT-Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy.	5 years
Secondary	Qulity of Sleep	Assessed by questionnaire:Pittsburg Sleep Quality INDEX, PSQI in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy	5 years
Secondary	Depression/Anxiety	Assessed by questionnaire: Hospital anxiety and depression Scale (HADS) in order to explore level of depression and anxiety in patients treated with radiation therapy for their brain tumour	5 years
Secondary	Patient's Assessment of Own Functioning Inventory	Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function	5 years