Exercise in Patients With Glioblastoma

• ClinicalTrials.gov Identifier: NCT03390569
• Recruitment Status: Active, not recruiting
• First Posted: January 4, 2018
• Last Update Posted: April 19, 2021
• Sponsor: University Health Network, Toronto
• Collaborators: Canadian Cancer Society (CCS); University of Toronto; McMaster University; University of British Columbia
• Information provided by (Responsible Party): University Health Network, Toronto

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.

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: N/A
• 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: August 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Canada, Ontario

Princess Margaret Hospital, University Health Network

Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Canadian Cancer Society (CCS)

University of Toronto

McMaster University

University of British Columbia

Investigators

• 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

More Information

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03390569
• Other Study ID Numbers: 16-5922
• First Posted: January 4, 2018
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

• 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:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue