NCT03390569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

September 27, 2017

Last Update Submit

April 13, 2022

Conditions

Glioblastoma

Keywords

GBMGlioblastomaBrain CancerHigh-Grade GliomaGlioma

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

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

    6 months

Secondary Outcomes (9)

  • Cognitive Decline

    3 months, 6 months, 12 months, 18 months post-treatment

  • Cognitive Complaints

    3 months, 6 months, 12 months, 18 months post-treatment

  • Overall survival

    Up to 18 months post-treatment

  • Personality Changes

    3, 6, 12 and 18 months post-treatment

  • Quality of Life

    3, 6, 12 and 18 months post-treatment

  • +4 more secondary outcomes

Study Arms (1)

Exercise in GBM

EXPERIMENTAL

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

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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.

Also known as: Fitness, Physiotherapy
Exercise in GBM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed glioblastoma
  • fluent in English
  • scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

GlioblastomaBrain NeoplasmsGlioma

Interventions

ExercisePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeuticsRehabilitation

Study Officials

  • Kim Edelstein, PhD, C.Psych.

    University of Toronto, University Health Network

    PRINCIPAL INVESTIGATOR

  • Warren Mason, MD

    University of Toronto, University Health Network

    PRINCIPAL INVESTIGATOR

  • Kristin Campbell, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

January 4, 2018

Study Start

August 29, 2017

Primary Completion

August 31, 2021

Study Completion

December 23, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

CA(1)