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Exercise in Patients With Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03390569
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Health Network, Toronto
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kim Edelstein, PhD, C.Psych.Warren Mason, MDKristin Campbell, PhD
Principal Investigator Affiliation University of Toronto, University Health NetworkUniversity of Toronto, University Health NetworkUniversity of British Columbia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

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).

Arms & Interventions

Arms

Experimental: Exercise in GBM

All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels

Interventions

Behavioral: - Exercise

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Toronto, Ontario, Canada

Status

Address

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9

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