Exercise in Patients With Glioblastoma

April 13, 2022 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Physiotherapy
  • Fitness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 6 months
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months, 6 months, 12 months, 18 months post-treatment
Cognitive Complaints
Time Frame: 3 months, 6 months, 12 months, 18 months post-treatment
as measured by a validated questionnaire
3 months, 6 months, 12 months, 18 months post-treatment
Overall survival
Time Frame: Up to 18 months post-treatment
rate of overall survival
Up to 18 months post-treatment
Personality Changes
Time Frame: 3, 6, 12 and 18 months post-treatment
as measured by a standardized questionnaire
3, 6, 12 and 18 months post-treatment
Quality of Life
Time Frame: 3, 6, 12 and 18 months post-treatment
as measured by a validated questionnaire
3, 6, 12 and 18 months post-treatment
Mood
Time Frame: 3, 6, 12 and 18 months post-treatment
as measured by a validated questionnaire
3, 6, 12 and 18 months post-treatment
Interference with valued activities and interests
Time Frame: 3, 6, 12 and 18 months post-treatment
as measured by a validated questionnaire
3, 6, 12 and 18 months post-treatment
Sleep Quality
Time Frame: 3, 6, 12 and 18 months post-treatment
as measured by a validated questionnaire
3, 6, 12 and 18 months post-treatment
Physical Function
Time Frame: 3, 6, 12 and 18 months post-treatment
strength, balance, cardiovascular endurance
3, 6, 12 and 18 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

University of British Columbia
McMaster University
University of Toronto
Canadian Cancer Society (CCS)

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 29, 2017

Primary Completion (ACTUAL)

August 31, 2021

Study Completion (ACTUAL)

December 23, 2021

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (ACTUAL)

January 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-5922

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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