Exercise in Patients With Glioblastoma

Glioblastoma Clinical Trial

Official title:

Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390569
• Other study ID #: 16-5922
• Status: Completed
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: December 23, 2021

Study information

• Verified date: April 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Secondary outcomes of interest include cognition, fatigue, and quality of life.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 23, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital, University Health Network	Toronto	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Cancer Society (CCS), McMaster University, University of British Columbia, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria	6 months
Secondary	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).	3 months, 6 months, 12 months, 18 months post-treatment
Secondary	Cognitive Complaints	as measured by a validated questionnaire	3 months, 6 months, 12 months, 18 months post-treatment
Secondary	Overall survival	rate of overall survival	Up to 18 months post-treatment
Secondary	Personality Changes	as measured by a standardized questionnaire	3, 6, 12 and 18 months post-treatment
Secondary	Quality of Life	as measured by a validated questionnaire	3, 6, 12 and 18 months post-treatment
Secondary	Mood	as measured by a validated questionnaire	3, 6, 12 and 18 months post-treatment
Secondary	Interference with valued activities and interests	as measured by a validated questionnaire	3, 6, 12 and 18 months post-treatment
Secondary	Sleep Quality	as measured by a validated questionnaire	3, 6, 12 and 18 months post-treatment
Secondary	Physical Function	strength, balance, cardiovascular endurance	3, 6, 12 and 18 months post-treatment