NCT05192447: REHABrain

The Cognitive-Behavioral Dysfunctions and the Potential of Neuroplasticity in Brain Tumors Patients During Radiotherapy

Status unknown NA Last updated 3 January 2024

What this trial tests

NA trial testing Exercise treatment in Brain Tumors in 150 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	The Greater Poland Cancer Centre
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	150
Start date	1 April 2021
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across Poland

Drugs / interventions tested

• Exercise treatment

Conditions studied

• Brain Tumors — all drugs for Brain Tumors →
• Radiotherapy — all drugs for Radiotherapy →

Sponsor

The Greater Poland Cancer Centre — full company profile →

Who can join

Adults 18 to 70, any sex, with Brain Tumors or Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rehabilitation Exercises Supported by Monitor-Augmented Reality for Patients with High-Grade Glioma Undergoing Radiotherapy: Results of a Randomized Clinical Trial.
   Pieczyńska A, Zasadzka E, Pilarska A, Procyk D, et al · · 2023 · cited 10× · PMID 37959303 · DOI 10.3390/jcm12216838
2. Neural and Onconeural Autoantibodies and Blood-Brain Barrier Disruption Markers in Patients Undergoing Radiotherapy for High-Grade Primary Brain Tumour.
   Hojan K, Adamska K, Lewandowska A, Procyk D, et al · · 2024 · cited 1× · PMID 38337823 · DOI 10.3390/diagnostics14030307
3. Does Personality Influence the Quality of Life of Patients with Brain Tumors Treated with Radiotherapy?
   Pilarska A, Pieczyńska A, Adamska K, Hojan K. · · 2025 · PMID 39796758 · DOI 10.3390/cancers17010131
4. Psychological Characteristics Associated with Post-Treatment Physical Status and Quality of Life in Patients with Brain Tumor Undergoing Radiotherapy.
   Pieczyńska A, Pilarska A, Adamska K, Zasadzka E, et al · · 2022 · PMID 36579602 · DOI 10.3390/jpm12111880