Exercise in Patients With Glioblastoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial

Conditions
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Glioblastoma

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed glioblastoma fluent in English scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment) Exclusion Criteria: brain metastases secondary to non-central nervous system cancer less than 18 years old receiving treatment at a location other than the Princess Margaret Cancer Centre deemed unfit to exercise by a study oncologist lack of fluency in English psychiatric or neurological disorders that could interfere with participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise in GBM<br>All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels | Behavioral: Exercise<br>* 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.<br>* Other names: Physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival | Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months, 6 months, 12 months, 18 months post-treatment | 
| Cognitive Complaints | as measured by a validated questionnaire | 3 months, 6 months, 12 months, 18 months post-treatment | 
| Overall survival | rate of overall survival | Up to 18 months post-treatment | 
| Personality Changes | as measured by a standardized questionnaire | 3, 6, 12 and 18 months post-treatment | 
| Quality of Life | as measured by a validated questionnaire | 3, 6, 12 and 18 months post-treatment | 
| Mood | as measured by a validated questionnaire | 3, 6, 12 and 18 months post-treatment | 
| Interference with valued activities and interests | as measured by a validated questionnaire | 3, 6, 12 and 18 months post-treatment | 
| Sleep Quality | as measured by a validated questionnaire | 3, 6, 12 and 18 months post-treatment | 
| Physical Function | strength, balance, cardiovascular endurance | 3, 6, 12 and 18 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBM, Glioblastoma, Brain Cancer, High-Grade Glioma, Glioma