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Exercise in Patients With Glioblastoma

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ClinicalTrials.gov Identifier: NCT03390569
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Canadian Cancer Society Research Institute (CCSRI)
University of Toronto
McMaster University
University of British Columbia
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Behavioral: Exercise Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise in GBM
All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels
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.
Other Names:
  • Fitness
  • Physiotherapy




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 6 months ]
    Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria


Secondary Outcome Measures :
  1. Cognitive Decline [ Time Frame: 3 months, 6 months, 12 months, 18 months post-treatment ]
    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).

  2. Cognitive Complaints [ Time Frame: 3 months, 6 months, 12 months, 18 months post-treatment ]
    as measured by a validated questionnaire

  3. Overall survival [ Time Frame: Up to 18 months post-treatment ]
    rate of overall survival

  4. Personality Changes [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a standardized questionnaire

  5. Quality of Life [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire

  6. Mood [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire

  7. Interference with valued activities and interests [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire

  8. Sleep Quality [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire

  9. Physical Function [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    strength, balance, cardiovascular endurance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390569


Contacts
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Contact: Irene Yacoub, BSc 416-340-4800 ext 5365 irene.yacoub@uhn.ca
Contact: Kim Edelstein, PhD 416-340-4800 ext 2737 kim.edelstein@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Irene Yacoub, BSc    416-340-4800 ext 5365    irene.yacoub@uhn.ca   
Contact: Kim Edelstein, PhD    416-340-4800 ext 2737    kim.edelstein@uhn.ca   
Principal Investigator: Kim Edelstein, PhD         
Principal Investigator: Warren Mason, MD         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Society Research Institute (CCSRI)
University of Toronto
McMaster University
University of British Columbia
Investigators
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Principal Investigator: Kim Edelstein, PhD, C.Psych. University of Toronto, University Health Network
Principal Investigator: Warren Mason, MD University of Toronto, University Health Network
Principal Investigator: Kristin Campbell, PhD University of British Columbia

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03390569     History of Changes
Other Study ID Numbers: 16-5922
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
GBM
Glioblastoma
Brain Cancer
High-Grade Glioma
Glioma
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue