The Neuro-protective Effects of Exercise in Children With Brain Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Hospital for Sick Children
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Donald Mabbott, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01944761
First received: August 15, 2013
Last updated: September 13, 2013
Last verified: August 2013
  Purpose

The objectives of our proposed study are to (a) evaluate the feasibility of conducting a structured exercise program in children treated with cranial radiation for brain tumors, (b) test whether exercise results in improved thinking skills and emotional function, and (c) examine potential mechanisms of improved outcome, particularly recovery of white matter and grey matter.


Condition Intervention
Brain Tumor
Behavioral: Exercise Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Neuro-protective Effects of Exercise in Children With Brain Tumors

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Feasibility of implementing an excercise intervention [ Time Frame: At week 42-45 ] [ Designated as safety issue: No ]
    We will look at several factors, including recruitment rate, exercise adherence rate, retention rate and participant/parent satisfaction to determine the feasability of this intervention


Secondary Outcome Measures:
  • Fitness [ Time Frame: Baseline, once at week 26-29 and once at week 42-45 ] [ Designated as safety issue: No ]
    Fitness will be measured using the volume of oxygen consumed while exercising at maximum capacity (VO2max) on a stationary bicycle.

  • Neuro-cognitive outcome [ Time Frame: Baseline, once at week 26-29 and once at week 42-45 ] [ Designated as safety issue: No ]
    Three neuro-cognitive processes important for cognitive development, and found to be sensitive to radiation injury, will be assessed. These measures of cognition include attention, information processing speed, and declarative memory.

  • Neural recovery (gliogenesis/neurogenesis) [ Time Frame: Baseline, once at week 26-29 and once at week 42-45 ] [ Designated as safety issue: No ]
    Changes in white matter integrity may occur as a result of gliogenesis and will be measured using Diffusion Tensor Imaging (DTI). Neurogenesis occurs primarily within the hippocampus, a structure important for learning a memory. Cerebral blood flow (CBF) has been demonstrated to be a potential surrogate imaging measure of neurogenesis. As such, we will use Arterial Spin Labeled (ASL) perfusion MRI to obtain estimates of CBF within the hippocampus.


Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Group
The 15 patients in this group will be randomized to start the 12 week exercise intervention without delay (immediate condition).
Behavioral: Exercise Program
Designed to improve cardio-respiratory fitness, the exercise program will be conducted for 12 weeks at a frequency of 3 sessions per week. Each exercise session will be conducted after school for a total duration of 90 minutes. First, training in a circuit of developmentally appropriate activities (30 minutes) will occur. Second, the training circuit will be followed by participation in an organized sport (i.e. 30 minutes of floor hockey, basketball, or indoor soccer). Following the workout sessions the children will receive a healthy snack and have an opportunity for socialization (30 minutes).
Experimental: Delayed Intervention
The 15 patients in this group will be randomized to start the intervention after the first group has completed the exercise intervention (delayed condition)
Behavioral: Exercise Program
Designed to improve cardio-respiratory fitness, the exercise program will be conducted for 12 weeks at a frequency of 3 sessions per week. Each exercise session will be conducted after school for a total duration of 90 minutes. First, training in a circuit of developmentally appropriate activities (30 minutes) will occur. Second, the training circuit will be followed by participation in an organized sport (i.e. 30 minutes of floor hockey, basketball, or indoor soccer). Following the workout sessions the children will receive a healthy snack and have an opportunity for socialization (30 minutes).

Detailed Description:

Brain tumors are the leading cause of death and disability from childhood disease in developed countries. With treatment advances over the last 25 years, survival rates have improved dramatically. However, survival is often achieved at considerable cost. Cranial radiation is frequently required for effective tumor control, and is associated with significant neuro-toxicity, including white matter damage and cognitive morbidity. In order to achieve the best possible outcome for survivors, and ultimately conquer the long-term consequences of this disease, new interventions must be developed to ameliorate the neuro-toxic effects experienced by children. radiation injury can now be used to guide the development of interventions designed to rescue neural tissue. Furthermore, various new agents and activities with potential to stimulate neuro-recovery are now available. The potential value of exercise for rescuing the brain from neuro-toxic effects, for instance, has recently been reported. Next, neuro-cognitive processes that are particularly sensitive to the effects of cranial radiation have been identified and can serve as behavioral assays to test the effectiveness of these new interventions. Finally, novel neuro-imaging tools are available to perform in vivo evaluations in order to delineate potential mechanisms of neuro-recovery. We intend to integrate these new research findings to develop and evaluate a physical exercise-based intervention targeted at rescuing brain tissue of children with brain tumors from the neuro-toxic impact of cranial radiation.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Survivors will be included if they are between 9 and 14 years of age. - - Survivors will be included if they either declare English as their native language or have had at least two years of schooling in English at the time of their first assessment.
  • Survivors must have been diagnosed with a hemispheric or posterior fossa tumor and been treated with cranial spinal or focal radiation.
  • No more than 7 years may have elapsed between diagnosis and time of study.
  • Survivors with a shunt will be included in the study, but will need to be identified prior to study on-set to discuss any specific considerations for imaging and physical activity.

Exclusion Criteria:

  • have a prior history of traumatic brain injury, neurological disorder, visual or sensory impairment, cerebral palsy, developmental delay or learning disability
  • are younger than 9 years (the delivery of an intervention program to young children carries challenges that make it difficult to include in an initial feasibility grant) or older than 14 years
  • require sedation for MRI imaging
  • severe neurological/motor dysfunction that would preclude safe participation in an exercise program.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944761

Contacts
Contact: Donald Mabbott, PhD (416) - 813 - 8875 donald.mabbott@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Donald Mabbott, PhD    (416) - 813 - 8875    donald.mabbott@sickkids.ca   
Principal Investigator: Donald Mabbott, PhD         
Sub-Investigator: Eric Bouffet, MD         
Sub-Investigator: Janine Piscione, PT         
Sub-Investigator: Suzanne Laughlin, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Donald Mabbott, PhD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Donald Mabbott, Psychologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01944761     History of Changes
Other Study ID Numbers: 1000019124
Study First Received: August 15, 2013
Last Updated: September 13, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatrics
Brain Tumor
Neuro-radiation
Exercise

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014