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Trial record 28 of 1118 for:    Recruiting, Not yet recruiting, Active, not recruiting, Completed, Enrolling by invitation, Approved for marketing Studies | glioblastoma

Exercise in Patients With Glioblastoma

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ClinicalTrials.gov Identifier: NCT03390569
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Canadian Cancer Society Research Institute (CCSRI)
University of Toronto
McMaster University
University of British Columbia
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE January 4, 2018
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE August 29, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
Progression-Free Survival [ Time Frame: 6 months ]
Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03390569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • 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).
  • Cognitive Complaints [ Time Frame: 3 months, 6 months, 12 months, 18 months post-treatment ]
    as measured by a validated questionnaire
  • Overall survival [ Time Frame: Up to 18 months post-treatment ]
    rate of overall survival
  • Personality Changes [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a standardized questionnaire
  • Quality of Life [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire
  • Mood [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire
  • Interference with valued activities and interests [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire
  • Sleep Quality [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    as measured by a validated questionnaire
  • Physical Function [ Time Frame: 3, 6, 12 and 18 months post-treatment ]
    strength, balance, cardiovascular endurance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise in Patients With Glioblastoma
Official Title  ICMJE Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Glioblastoma
Intervention  ICMJE 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:
  • Fitness
  • Physiotherapy
Study Arms  ICMJE Experimental: Exercise in GBM
All patients will be assigned a three-month exercise intervention according to their own capabilities and current activity levels
Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2018)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Irene Yacoub, BSc 416-340-4800 ext 5365 irene.yacoub@uhn.ca
Contact: Kim Edelstein, PhD 416-340-4800 ext 2737 kim.edelstein@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03390569
Other Study ID Numbers  ICMJE 16-5922
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE
  • Canadian Cancer Society Research Institute (CCSRI)
  • University of Toronto
  • McMaster University
  • University of British Columbia
Investigators  ICMJE
Principal Investigator: 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
PRS Account University Health Network, Toronto
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP