Exercise in Patients With Glioblastoma

NCT ID: NCT03390569

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2021-12-23

Brief Summary

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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

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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

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise in GBM

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Fitness Physiotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim Edelstein, PhD, C.Psych.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, University Health Network

Warren Mason, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, University Health Network

Kristin Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Princess Margaret Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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16-5922

Identifier Type: -

Identifier Source: org_study_id

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