Patients with newly-diagnosed GBM will be given personalized exercise regimes during concurrent chemo-radiation and up to 3 months later. Study aims are to investigate the feasibility and preliminary efficacy of the exercise program on progression free survival. Secondary outcomes of interest include cognition, fatigue, and quality of life.
Background: Glioblastoma (GBM) is the most common malignant glioma in adults, with a very poor prognosis, limited new treatment options, and neurological sequelae, including physical and cognitive decline that adversely affect quality of life (QOL). Physical activity may be an intervention that attenuates the cognitive and physical decline associated with GBM. However, few studies examine physical activity in brain tumor patients, perhaps due to challenges in trial design, measuring outcomes, and complexity of care. Aims of this work are to develop and implement an individualized exercise intervention for GBM patients to support functional independence, and to delay tumor progression and cognitive decline. Methods: GBM patients scheduled to be treated with concurrent radiation and chemotherapy will be recruited from the neuro-oncology clinic at the Princess Margaret Cancer Centre. Participants will receive an individualized, home-based exercise program that includes aerobic and resistance training, tailored to prior level of fitness, current physical status, and individual interests. They will undergo 1-hr standardized, validated assessments of physical and neurocognitive functions, mood, fatigue, and QOL, prior to radiation, and then 3, 6, 12, and 18 months later. Significance: Identifying interventions that preserve or improve mobility and cognitive function will enhance QOL and may lengthen progression-free survival in brain tumor patients. Moreover, finding ways to help patients maintain self-care will lessen the strain on the health care system (e.g., fewer hospitalizations, delayed utilization of palliative care hospice).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
54
The patients meet with a registered physiotherapist and receive individualized exercise programs starting the second week of treatment, and continuing up to 3 months later.
Princess Margaret Hospital, University Health Network
Toronto, Ontario, Canada
Progression-Free Survival
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: 6 months
Cognitive Decline
Tests will be scored according to published criteria, converted to z-scores based on population norms, and averaged to create an overall cognitive function score. COgnitive decline will be defined as declined scores at a given time point (preservation of cognitive functions will be defined as stable or improved scores at a given time point).
Time frame: 3 months, 6 months, 12 months, 18 months post-treatment
Cognitive Complaints
as measured by a validated questionnaire
Time frame: 3 months, 6 months, 12 months, 18 months post-treatment
Overall survival
rate of overall survival
Time frame: Up to 18 months post-treatment
Personality Changes
as measured by a standardized questionnaire
Time frame: 3, 6, 12 and 18 months post-treatment
Quality of Life
as measured by a validated questionnaire
Time frame: 3, 6, 12 and 18 months post-treatment
Mood
as measured by a validated questionnaire
Time frame: 3, 6, 12 and 18 months post-treatment
Interference with valued activities and interests
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as measured by a validated questionnaire
Time frame: 3, 6, 12 and 18 months post-treatment
Sleep Quality
as measured by a validated questionnaire
Time frame: 3, 6, 12 and 18 months post-treatment
Physical Function
strength, balance, cardiovascular endurance
Time frame: 3, 6, 12 and 18 months post-treatment