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

Summary

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

• Brain Tumors
• Radiotherapy

Interventions

BEHAVIORAL

Exercise treatment

Patients selected to EG will carry out complementary cognitive and physical training under supervision of rehabilitation staff. For neuropsychological exercises, the investigators will use the RehaCom system - high quality scientific neurocognitive disorder therapy programs and software. (Time: 30 min./5 times/week per patient during RT). In this time, EG patients will do physical training (such as cycling, running on properly calibrated equipment for the circulatory system parameter measurement (1hour/ 5 days/ week), and neuromuscular and cognitive reeducation exercises using a technically advanced tool - Neuroforma computer software - 30 min/ 5 times/ week). After the end of RT, patients in EG will do a special exercise training at home under supervision of staff from the Department of Rehabilitation, and cognitive training using special tasks (3 times an hour/per week) at home, and two times/week using RehaCom and Neuroforma (60 min/sesion) in our cancer ceter.

Sponsors & Collaborators

• National Science Centre, Poland

  collaborator OTHER_GOV

• The Greater Poland Cancer Centre

  lead OTHER

Principal Investigators

• Katarzyna Hojan, MD, PhD · Greater Poland Cancer Centre

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Poland

Study Locations