Cerebral Morbidity After Radiation Therapy for Brain Tumors

Active, not recruiting

• Conditions: Radiation Toxicity; Brain Tumor; Cognitive Impairment

• Registration Number: NCT04292353
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-03
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-05
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 67

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

Read More

Exclusion Criteria

• Glioblastoma
• Performance status 3-4

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impairment of memory as assessed by the HVLT-r test	5 Years	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)

Secondary Outcome Measures

Name	Time	Method
Verbal fluency	5 Years	Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter_S. Outcome is number of words produced in 1 minute (0-100)
Processing speed	5 Years	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)
Executive function	5 Years	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)
Verbal learning and memory	5 Years	Examine by the Hopkins Verbal Learning Test (HVLT) - total and delayed. Outcome is number of correct words (0-24)
Fatigue	5 years	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.
Qulity of Sleep	5 years	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
Depression/Anxiety	5 years	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
Global Health - Quality of life	5 Years	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
Patient's Assessment of Own Functioning Inventory	5 years	Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function
Attention and working memory	5 Years	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)

Trial Locations

Locations (4)

Rigshospital; 🇩🇰 Copenhagen, Region H, Denmark

Department of Oncology; 🇩🇰 Aarhus, Region Midt, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Region Nord, Denmark

Odense University Hospital; 🇩🇰 Odense, Region Syd, Denmark