Exercise in Patients With Glioblastoma
Primary Purpose
Glioblastoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Glioblastoma focused on measuring GBM, Glioblastoma, Brain Cancer, High-Grade Glioma, Glioma
Eligibility Criteria
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
Sites / Locations
- Princess Margaret Hospital, University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise in GBM
Arm Description
All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels
Outcomes
Primary Outcome Measures
Progression-Free Survival
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
Secondary Outcome Measures
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).
Cognitive Complaints
as measured by a validated questionnaire
Overall survival
rate of overall survival
Personality Changes
as measured by a standardized questionnaire
Quality of Life
as measured by a validated questionnaire
Mood
as measured by a validated questionnaire
Interference with valued activities and interests
as measured by a validated questionnaire
Sleep Quality
as measured by a validated questionnaire
Physical Function
strength, balance, cardiovascular endurance
Full Information
NCT ID
NCT03390569
First Posted
September 27, 2017
Last Updated
April 13, 2022
Sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Society (CCS), University of Toronto, McMaster University, University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03390569
Brief Title
Exercise in Patients With Glioblastoma
Official Title
Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Cancer Society (CCS), University of Toronto, McMaster University, University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
GBM, Glioblastoma, Brain Cancer, High-Grade Glioma, Glioma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise in GBM
Arm Type
Experimental
Arm Description
All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
Fitness, Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cognitive Decline
Description
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
Title
Cognitive Complaints
Description
as measured by a validated questionnaire
Time Frame
3 months, 6 months, 12 months, 18 months post-treatment
Title
Overall survival
Description
rate of overall survival
Time Frame
Up to 18 months post-treatment
Title
Personality Changes
Description
as measured by a standardized questionnaire
Time Frame
3, 6, 12 and 18 months post-treatment
Title
Quality of Life
Description
as measured by a validated questionnaire
Time Frame
3, 6, 12 and 18 months post-treatment
Title
Mood
Description
as measured by a validated questionnaire
Time Frame
3, 6, 12 and 18 months post-treatment
Title
Interference with valued activities and interests
Description
as measured by a validated questionnaire
Time Frame
3, 6, 12 and 18 months post-treatment
Title
Sleep Quality
Description
as measured by a validated questionnaire
Time Frame
3, 6, 12 and 18 months post-treatment
Title
Physical Function
Description
strength, balance, cardiovascular endurance
Time Frame
3, 6, 12 and 18 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Edelstein, PhD, C.Psych.
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren Mason, MD
Organizational Affiliation
University of Toronto, University Health Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristin Campbell, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
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Exercise in Patients With Glioblastoma
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