Cognitive Function After Radiation Therapy for Brain Tumours

NCT04118426 | Completed

• 1 other identifier: WP-12's precursor
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). All types of brain tumours apart from glioblastoma will be included

Conditions

Primary Brain Tumor; Radiation Toxicity

Keywords

Cognitive function

Outcome Measures

Primary Outcomes (2)

• Memory impairment (as assessed by the HVLT-r)

  To examine the correlation between memory impairment (assessed by HVLT-r) and mean dose to the hippocampus.

  1-10 years after treatment

• Neurocognitive function

  Examine correlations cognitive decline and subvolumes of the brain. Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP). Measures on cognitive test is time in seconds or number of "corrects".

  1-10 years after treatment

Secondary Outcomes (5)

• Global Health - Quality of life

  1-10 years after treatment

• Fatigue

  1-10 years after treatment

• Sleep quality

  1-10 years after treatment

• Depression/Anxiety

  1-10 years after treatment

• Patients assessment of own cognitive function

  1-10 years after treatment

Study Arms (2)

Radiotherapy group

Patients receiving radiotherapy after surgery for brain tumor

Radiation: Cognitive testing

No radiotherapy group

Patients NOT receiving radiotherapy after surgery for brain tumor

Radiation: Cognitive testing

Interventions

Cognitive testing RADIATION

Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires. Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP) Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI).

No radiotherapy group; Radiotherapy group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a primary brain tumour grade I-III

You may qualify if:

• The participant must be 18 years or older and Danish speaking.
• Performance status 0-2
• Capable of cooperating on testing
• Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016
• ZM93803 glioma (exclusive glioblastoma)
• ZM9401/3 anaplastic astrocytoma, IDH mutant
• ZM9400/3 diffuse astrocytoma, IDH-mutant
• ZM9411/3 gemistocytisk astrocytoma, IDH mutant
• ZM9400/3 diffuse astrocytoma, NOS
• ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted
• ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
• ZM9450/3 oligodendroglioma, NOS
• ZM9451/3 anaplastic oligodendroglioma, NOS
• ZM9530/0 meningioma
• ZM9470/3 medulloblastoma, NOS

You may not qualify if:

• Performance status 3-4 Progression after radiation therapy

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Location

Related Publications (1)

• Haldbo-Classen L, Amidi A, Lukacova S, Wu LM, Oettingen GV, Lassen-Ramshad Y, Zachariae R, Kallehauge JF, Hoyer M. Cognitive impairment following radiation to hippocampus and other brain structures in adults with primary brain tumours. Radiother Oncol. 2020 Jul;148:1-7. doi: 10.1016/j.radonc.2020.03.023. Epub 2020 Mar 28.

  PMID: 32298906 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Radiation Injuries

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Morten Høyer, M.D.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: October 8, 2019
• Study Start: February 7, 2017
• Primary Completion: February 2, 2018
• Study Completion: April 12, 2018
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)