Clinical trial · Interventional
The Cognitive-Behavioral Dysfunctions and the Potential of Neuroplasticity in Brain Tumors Patients During Radiotherapy
Analysis of the Cognitive-behavioral Dysfunctions Profile and the Potential of Neuroplasticity in Patients With Brain Tumors Subjected to Selected Radiotherapy Techniques and the Possibility of Their Compensation by Psycho-physical Training
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary and secondary brain tumors are a constant challenge for the medicine. Tissue sensitivity to ionizing radiation differs and depends on numerous factors and the same dose of radiation may produce different effects in particular structures of the CNS. It can also affect the surrounding healthy tissues and lead to adverse effects like the cognitive or physical function impairment. One of brain structures most sensitive to ionizing radiation is the limbic system, especially the hippocampus, because it is here that the postnatal neurogenesis takes place via neural stem cells, which are a self-renewing population of precursor cells. There have been no studies that would thoroughly examine the impact of different CNS radiation therapy techniques on the cognitive function, potential neuroplasticity markers or blood-brain barrier damage in brain tumor patients with a concomitant use of neurocognitive combination therapies or physical exercise, and their impact on the CNS function. The aim of the study is to assess the impact of selected RT techniques: IMRT, WBRT, and CyberKnife (SRS) on the processes regulating cognitive and physical function in patients with primary (Group III and IV, WHO, 2016) and metastatic CNS tumors. The secondary objective is the analysis of the effect of selected forms of neurorehabilitation on the parameters studied. The study will be a prospective clinical trial conducted in 150 patients. Patient evaluation will be carried out before RT, after RT, during a follow-up visit-3 months after RT, and finally after 6 months. The methods will be used: analysis of the blood-brain barrier permeability markers including exact connection proteins, markers confirming neuroplasticity of the brain, cerebral secretory activity, and onco- and anti-neuronal antibody activity, brain structure analysis (MRI) and volume testing of selected brain structures, and assessment of cognitive and physical function of the patients. The study will be a part of the search trend aiming to explain the mechanism of the formation of cognitive-behavioral disorders in humans based on the most fundamental principles governing information processing in CNS, and the impact of neoplasia and ionizing radiation on selected brain structures and functions. The results of the study might become a starting point for the formulation of new guidelines on the level of physical activity or cognitive exercise in patients treated with CNS radiation therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise treatment | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group = Exercise Group
- description
- EG will perform complementary cognitive and physical training (120 min./5/per week during study observation)
- interventionNames
- Behavioral: Exercise treatment
- type
- NO_INTERVENTION
- label
- Control Group
- description
- CG will be provided with normal hospital care during RT and next will conduct a normal daily activity at home.
Primary outcomes (3)
- measure
- Markers of BBB disruption
- timeFrame
- up to 48 months
- description
- The astrocytic protein S-100β will be estimated using enzyme-linked immunoassay (ELISA).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria: * Patients with three different CNS groups of tumors: from III and IV brain tumor groups, and metastatic tumors enrolled to RT, * Age between 18-70 years, * good general health conditions (according to Eastern Cooperative Oncology Group (ECOG) 0-2), * obtaining informed consent for participation in the study. Exclusion criteria: * Patients with numerous tumors (above two), * psychological or psychiatric illnesses treated pharmacologically, * neurological disorders (e.g. MS, Parkinson's disease, meningitis, etc.), * significant clinical circulatory failure (above III NYHA).
References
Publications (18)
- BACKGROUNDAttia A, Page BR, Lesser GJ, Chan M. Treatment of radiation-induced cognitive decline. Curr Treat Options Oncol. 2014 Dec;15(4):539-50. doi: 10.1007/s11864-014-0307-3. PMID 25228143
- BACKGROUNDBaillieux H, De Smet HJ, Paquier PF, De Deyn PP, Marien P. Cerebellar neurocognition: insights into the bottom of the brain. Clin Neurol Neurosurg. 2008 Sep;110(8):763-73. doi: 10.1016/j.clineuro.2008.05.013. Epub 2008 Jul 7. PMID 18602745
- BACKGROUNDBenraiss A, Chmielnicki E, Lerner K, Roh D, Goldman SA. Adenoviral brain-derived neurotrophic factor induces both neostriatal and olfactory neuronal recruitment from endogenous progenitor cells in the adult forebrain. J Neurosci. 2001 Sep 1;21(17):6718-31. doi: 10.1523/JNEUROSCI.21-17-06718.2001. PMID 11517261
- BACKGROUNDBlyth BJ, Farhavar A, Gee C, Hawthorn B, He H, Nayak A, Stocklein V, Bazarian JJ. Validation of serum markers for blood-brain barrier disruption in traumatic brain injury. J Neurotrauma. 2009 Sep;26(9):1497-1507. doi: 10.1089/neu.2008.0738. PMID 19257803
- BACKGROUNDFischl B. FreeSurfer. Neuroimage. 2012 Aug 15;62(2):774-81. doi: 10.1016/j.neuroimage.2012.01.021. Epub 2012 Jan 10. PMID 22248573
- BACKGROUNDGreene-Schloesser D, Moore E, Robbins ME. Molecular pathways: radiation-induced cognitive impairment. Clin Cancer Res. 2013 May 1;19(9):2294-300. doi: 10.1158/1078-0432.CCR-11-2903. Epub 2013 Feb 6. PMID 23388505
- BACKGROUNDHipkiss AR, Cartwright SP, Bromley C, Gross SR, Bill RM. Carnosine: can understanding its actions on energy metabolism and protein homeostasis inform its therapeutic potential? Chem Cent J. 2013 Feb 25;7(1):38. doi: 10.1186/1752-153X-7-38. PMID 23442334
- Kanner AA, Marchi N, Fazio V, Mayberg MR, Koltz MT, Siomin V, Stevens GH, Masaryk T, Aumayr B, Vogelbaum MA, Barnett GH, Janigro D. Serum S100beta: a noninvasive marker of blood-brain barrier function and brain lesions. Cancer. 2003 Jun 1;97(11):2806-13. doi: 10.1002/cncr.11409.