Clinical trial NCT03390569: Exercise in Patients With Glioblastoma
Official title: Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Keywords: GBM
Glioblastoma
Brain Cancer
High-Grade Glioma
Glioma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: University of Toronto
name: McMaster University
name: University of British Columbia
First posted: 2018-01-04
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Cognitive Decline
timeFrame: 3 months, 6 months, 12 months, 18 months post-treatment
measure: Cognitive Complaints
timeFrame: 3 months, 6 months, 12 months, 18 months post-treatment
measure: Overall survival
timeFrame: Up to 18 months post-treatment
measure: Personality Changes
timeFrame: 3, 6, 12 and 18 months post-treatment
measure: Quality of Life
timeFrame: 3, 6, 12 and 18 months post-treatment
measure: Mood
timeFrame: 3, 6, 12 and 18 months post-treatment
measure: Interference with valued activities and interests
timeFrame: 3, 6, 12 and 18 months post-treatment
measure: Sleep Quality
timeFrame: 3, 6, 12 and 18 months post-treatment
measure: Physical Function
timeFrame: 3, 6, 12 and 18 months post-treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital, University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto, University Health Network
name: Kim Edelstein, PhD, C.Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, University Health Network
name: Warren Mason, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Kristin Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: