GlioblastomaNCT03390569
Exercise in Patients With Glioblastoma
A study testing Exercise in people with Glioblastoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 29 Aug 2017to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed glioblastoma
- fluent in English
- scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9
About this study
Official title: Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial
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.
Read the 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).
- Conditions
- Glioblastoma
- Being tested
- Exercise
- Keywords
- GBM, Glioblastoma, Brain Cancer, High-Grade Glioma, Glioma
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Fitness, Physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise in GBM | Experimental | All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
Measured: 6 months
Secondary outcomes (9)
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).
Measured: 3 months, 6 months, 12 months, 18 months post-treatment
Cognitive Complaints
as measured by a validated questionnaire
Measured: 3 months, 6 months, 12 months, 18 months post-treatment
Overall survival
rate of overall survival
Measured: Up to 18 months post-treatment
Personality Changes
as measured by a standardized questionnaire
Measured: 3, 6, 12 and 18 months post-treatment
Quality of Life
as measured by a validated questionnaire
Measured: 3, 6, 12 and 18 months post-treatment
Mood
as measured by a validated questionnaire
Measured: 3, 6, 12 and 18 months post-treatment
Interference with valued activities and interests
as measured by a validated questionnaire
Measured: 3, 6, 12 and 18 months post-treatment
Sleep Quality
as measured by a validated questionnaire
Measured: 3, 6, 12 and 18 months post-treatment
Physical Function
strength, balance, cardiovascular endurance
Measured: 3, 6, 12 and 18 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start29 Aug 2017
- Primary completion31 Aug 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), University of Toronto, McMaster University, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Kim Edelstein, PhD, C.Psych., Principal investigator, University of Toronto, University Health NetworkWarren Mason, MD, Principal investigator, University of Toronto, University Health NetworkKristin Campbell, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390569
- Sponsor's protocol ID
- 16-5922
- Status last verified
- Apr 2022
- First submitted
- 27 Sep 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial
- ClinicalTrials.gov ID
- NCT03390569
- Acronym / sponsor ID
- 16-5922
- Conditions
- Glioblastoma
- Keywords
- GBM, Glioblastoma, Brain Cancer, High-Grade Glioma, Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS), University of Toronto, McMaster University, University of British Columbia
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise in GBM | Experimental | Behavioral: ExerciseAll patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- newly diagnosed glioblastoma
- fluent in English
- scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Fitness, PhysiotherapyThe patients meet with a registered physiotherapist and receive individualized exercise programs starting the second week of treatment, and continuing up to 3 months later. | Behavioural | Exercise in GBM |
Primary outcome
Progression-Free Survival
Time frame: 6 months
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
9 secondary outcomes
Cognitive Decline
Time frame: 3 months, 6 months, 12 months, 18 months post-treatment
Cognitive Complaints
Time frame: 3 months, 6 months, 12 months, 18 months post-treatment
Overall survival
Time frame: Up to 18 months post-treatment
Personality Changes
Time frame: 3, 6, 12 and 18 months post-treatment
Quality of Life
Time frame: 3, 6, 12 and 18 months post-treatment
Mood
Time frame: 3, 6, 12 and 18 months post-treatment
Interference with valued activities and interests
Time frame: 3, 6, 12 and 18 months post-treatment
Sleep Quality
Time frame: 3, 6, 12 and 18 months post-treatment
Physical Function
Time frame: 3, 6, 12 and 18 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Edelstein, PhD, C.Psych. principal investigator
University of Toronto, University Health Network
Warren Mason, MD principal investigator
University of Toronto, University Health Network
Kristin Campbell, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Glioblastoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.