Neuropsychological functioning and quality of life of adult patients with brain tumor = 3 years after proton irradiation: an examination of late effects of treatment

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034954

Enrollment

Registered

2024-08-28

Start date

2024-04-10

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astrocytoma (WHO II-III), meningioma, craniopharyngioma, ependymoma, chordoma and chondrosarcoma in the area of the head

Interventions

Group 1: Adult patients with brain tumors at least 3 years after completion of radiation therapy with protons Verbal learning and memorization skills: California Verbal Learning Test (CVLT) Formal le

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnoses: Astrocytoma (WHO II-III), meningioma, craniopharyngioma, ependymoma, chordoma and chondrosarcoma in the area of the head - Proton therapy at the WPE (from 2013) - Minimum interval between proton therapy and study entry = 3 years - Participation in the registry study Standard Proton Therapy WPE - Adults - (12-5143-BO) - Proficiency in written and spoken German

Exclusion criteria

Exclusion criteria: - visual and/or auditory impairments (which may distort the neuropsychological test results), unless these are compensated for by prescribed aids (e.g. glasses, hearing aid) - Severe neurological or other health complications (e.g. spasticity, tendency to seizures) - Recurrence or progression since the end of radiotherapy

Design outcomes

Primary

Measure	Time frame
The primary objective is to examine various aspects of the treatment outcome of proton therapy. This includes the assessment of neuropsychological functional performance as well as the evaluation of quality of life in relation to the deviation of the determined neuropsychological performance and quality of life in comparison to test experience values. The comparison between the determined results and test experience values should be made on the basis of a) the result interval between the average results of each neuropsychological test or the quality of life results in healthy persons (normal values) and the corresponding results reported in the literature after radiation treatment, b) the interval of one standard deviation below the respective average value (standard mean value) of the neuropsychological tests or quality of life results	—

Measure

Time frame

The primary objective is to examine various aspects of the treatment outcome of proton therapy. This includes the assessment of neuropsychological functional performance as well as the evaluation of quality of life in relation to the deviation of the determined neuropsychological performance and quality of life in comparison to test experience values. The comparison between the determined results and test experience values should be made on the basis of a) the result interval between the average results of each neuropsychological test or the quality of life results in healthy persons (normal values) and the corresponding results reported in the literature after radiation treatment, b) the interval of one standard deviation below the respective average value (standard mean value) of the neuropsychological tests or quality of life results

—

Secondary

Measure	Time frame
The secondary objective is to test the feasibility of the following aspects: - Patient management - Test performance and acceptance	—

Countries

Germany

Contacts

Public ContactKristy Köhler

Westdeutsches Protonentherapiezentrum Essen (WPE)

kristy.koehler@uk-essen.de+49 201/723 6608

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026