Cognitive Function After Radiation Therapy for Primary Brain Tumours
NCT04306432, Recruiting, University of Aarhus
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Function After Radiation Therapy for Primary Brain Tumours | ClinicalTrials.gov |
| NCT number | NCT04306432 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Aarhus | ClinicalTrials.gov |
| Conditions | Primary Brain Tumour, Radiation Toxicity, Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Cognitive tests and Patient Reported Outcomes | ClinicalTrials.gov |
| First posted | 2020-03-12 | ClinicalTrials.gov |
| Last updated | 2021-12-02 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Impairment of verbal learning and memory as assessed by the HVLT-r test | 10 Years | Examined by the Hopkins Verbal Learning Test revised. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24) | ClinicalTrials.gov |
| Secondary | Processing speed I | 10 years | Examined by the Trail making Test part A (TMT\_A). Outcome for TMT\_A is time in seconds (0-120 seconds). | ClinicalTrials.gov |
| Secondary | Processing speed II | 10 years | Examined by the Coding from Wechsler Adult Intelligence Scale (WAIS-IV). Outcome for Coding is number of correct (within 2 minutes) (0-100) | ClinicalTrials.gov |
| Secondary | Attention and working memory | 10 years | Examined by Wechsler Adult Intelligence Scale (WAIS\_IV\_digit\_span). Outcome on WAIS digit span is number of correct (0-36) | ClinicalTrials.gov |
| Secondary | Verbal learning and memory | 10 years | Examine by the Hopkins Verbal Learning Test revised (HVLT-r) - total and delayed. Outcome is number of correct words (0-24) | ClinicalTrials.gov |
| Secondary | Verbal fluency | 10 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) | ClinicalTrials.gov |
| Secondary | Executive function I | 10 years | Examined by Trail making Test part B (TMT\_B). Outcome for TMT\_B is time in seconds (0-300). | ClinicalTrials.gov |
| Secondary | Executive function II | 10 years | Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120) | ClinicalTrials.gov |
| Secondary | Global Health - Quality of life | 10 years | Assessed by questionnaire; European organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. The total score is a number (0-100) | ClinicalTrials.gov |
| Secondary | Side effects to radiation therapy | 10 years | Assessed by EORTC Brain Neoplasm Questionnaire, BN20 (an addition to QLQ-C30 mentioned above) in order to measure side effects to radiation therapy for a brain tumour. the score is a number (0-100) | ClinicalTrials.gov |
| Secondary | Quality of Sleep | 10 years | Assessed by questionnaire: Pittsburgh Sleep Quality INDEX, (PSQI) in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy. Outcome is a number (0-33) | ClinicalTrials.gov |
| Secondary | Fatigue | 10 years | Assessed by questionnaire: Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy. Outcome is a number (0-52) | ClinicalTrials.gov |
| Secondary | Depression/Anxiety | 10 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. Outcome is a number (0-56) | ClinicalTrials.gov |
| Secondary | Patient's Assessment of Own Functioning | 10 years | Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function. Outcome is a number (35-210) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)