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Completed

NCT Number: NCT03390569

Exercise in Patients With Glioblastoma

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

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.

Other names: Fitness, Physiotherapy

Primary outcomes

  1. Progression-Free Survival

    Time frame: 6 months

    Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 4, 2018
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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