search
Back to results

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour (Met Med Can)

Primary Purpose

Medulloblastoma, Childhood, Cognitive Impairment

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Metformin hydrochloride (HCl) 500mg tablet
Placebo
Sponsored by
Donald Mabbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Medulloblastoma, Childhood focused on measuring Metformin, Paediatric brain tumour, Memory, Cognitive late effects

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. No less than 3 weeks after completion of primary therapy for medulloblastoma
  2. Age 7 years to 17 years and 11 months at the time of enrollment
  3. Either declare English (or French in accepting sites) as their native language or have had at least two years of schooling in English (or French in accepting sites) at the time of consent
  4. Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen
  5. Meet criteria for normal organ function requirements as described below:

    1. Normal renal function defined as: Estimated glomerular filtration rate (eGFR) > 75ml/min/1.73m²

      • eGFR is calculated using the Schwartz formula: eGFR (mL/min/1.73m²) = (0.41 × height in cm) / creatinine in mg/dL
    2. Normal liver function defined as:

      • Serum glutamic-oxaloacetic transaminase (SGOT) (AST) <1.5 institutional upper limit of normal (ULN) for age and gender
      • Serum glutamic pyruvic transaminase (SGPT) (ALT) <1.5 institutional ULN for age and gender
      • Total bilirubin <1.5 institutional ULN for age and gender
  6. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardian(s) by study team members delegated to consent for this study

Exclusion Criteria:

Participants who meet any of the following criteria will not be eligible to take part in the trial:

  1. Unable to participate in MRI without sedation
  2. Standard score of less than 60 for full scale IQ on the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) (for English speaking participants) or pro-rated IQ score on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) (for French speaking participants) at Screening visit
  3. Have a known hypersensitivity to metformin hydrochloride
  4. Have unstable and/or insulin-dependent (Type 1) diabetes
  5. Have a history of hypoglycemia after 2 years of age
  6. Have been diagnosed with acute or chronic metabolic acidosis and/or lactic acidosis or have a lactate level greater than 5 mmol/L at the Screening visit
  7. Have a history of renal disease or renal dysfunction
  8. Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry
  9. Currently taking part in a cognitive rehabilitation intervention study
  10. Treatment or planned treatment involving diuretics
  11. Current or planned treatment with cationic drugs excreted by the kidneys (e.g. amiloride, cimetidine, digoxin, morphine, nifedipine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin)
  12. Current or planned treatment with concomitant medications with potential unacceptable interaction with metformin including topiramate, lamotrigine, levetiracetam, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, glycopyrrolate, and carbonic anhydrase inhibitors, or at the discretion of the Site PI or delegate for medications with potential interactions such as sertraline, lansoprazole and omeprazole.
  13. Pernicious anemia (according to results of the Screening visit blood draw)
  14. Current use of metformin hydrochloride
  15. Any condition or diagnosis, that could in the opinion of the Site PI or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk

Sites / Locations

  • John Hunter Children's HospitalRecruiting
  • Children's Hospital in Westmead
  • Monash Children's HospitalRecruiting
  • Royal Children's HospitalRecruiting
  • Perth Children's Hospital
  • Alberta Children's HospitalRecruiting
  • Stollery Children's HospitalRecruiting
  • Children's & Women's Health Centre of British ColumbiaRecruiting
  • Cancer Care Manitoba
  • Izaak Walton Killam (IWK) Health CentreRecruiting
  • Hamilton Health Sciences - McMaster Children's HospitalRecruiting
  • Children's Hospital, London Health Sciences CentreRecruiting
  • Children's Hospital of Eastern OntarioRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • CHU Sainte-JustineRecruiting
  • Montreal Children's HospitalRecruiting
  • CHU de Québec - Université LavalRecruiting
  • CHU de Sherbrooke
  • Saskatchewan Health Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Oral metformin will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).

Oral placebo will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).

Outcomes

Primary Outcome Measures

Change from Week 1 (Baseline) Children's Auditory Verbal Learning Test-2 (CAVLT-2)/Rey Auditory Verbal Learning Test (RAVLT) Immediate Recall at Week 17 (Post-Intervention) to Assess Declarative Memory
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for improving cognition, as measured by CAVLT-2/RAVLT which is a test of auditory verbal learning and memory.
Change from Week 1 (Baseline) NIH Toolbox List Sort Working Working Memory Test at Week 17 (Post-Intervention) to Assess Working Memory
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for improving cognition, as measured by List Sorting Working Memory Test (LSWMT) in which participants will be required to recall and place in sequence stimuli that are presented visually and verbally.
Change from Week 1 (Baseline) Cambridge Neuropsychological Test Automated Battery (CANTAB) Mean Reaction Time for Correct Trials across the RVP, RTI, MTS, and DMS Subtests at Week 17 (Post-Intervention) to Assess Processing Speed
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for improving cognition, as measured by mean reaction time for correct trials across subtests of the CANTAB: Rapid Visual Information Processing (RVP) Reaction Time (RTI) Match to Sample Visual Search (MTS) Delayed Matching to Sample (DMS) Each subtest provides an outcome measure of response latency, which will be averaged across all correct trials for each subtest to provide an overall measure of processing speed.

Secondary Outcome Measures

Diffusion Kurtosis Imaging (DKI) to Assess White Matter Growth within the Corpus Callosum
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for promoting white matter growth within the corpus callosum as measured by DKI including axonal water fraction (AWF), a metric sensitive to myelin.

Full Information

First Posted
January 12, 2022
Last Updated
February 10, 2023
Sponsor
Donald Mabbott
search

1. Study Identification

Unique Protocol Identification Number
NCT05230758
Brief Title
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Acronym
Met Med Can
Official Title
Phase III Randomized Double-blind Placebo-controlled Trial of Metformin for Cognitive Recovery and White Matter Growth in Paediatric Medulloblastoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Donald Mabbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children/adolescents treated for medulloblastoma will be investigated in a multi-site Phase III randomized double-blind placebo-controlled parallel arm superiority trial. Specifically, in children/adolescents aged 7 years to 17 years and 11 months who have completed treatment for medulloblastoma, is oral administration of metformin for 16 weeks associated with greater improvement of cognitive function and brain growth compared to placebo administered for 16 weeks?
Detailed Description
A critical barrier to improving the quality of life of children/adolescents living with cancer is that our curative therapies, which include a combination of surgery, chemotherapy and radiation, have toxic effects on healthy tissue, resulting in long-term problems. This is evident for children and adolescents who survive medulloblastoma - a brain tumour requiring aggressive therapy: they experience brain injury and cognitive impairment. There are few therapies for restoring cognitive function and promoting brain growth in survivors; however new work in regenerative medicine offers a possible alternative. The drug metformin promotes brain growth in animal models by activating neural stem cells. In a pilot trial with 24 participants, we found that metformin was safe and tolerable for use in children/adolescents treated with cranial radiation for a brain tumour and may improve cognition and promote white matter growth. In this multi-site clinical trial, we will test the efficacy of treatment with metformin for brain repair and cognitive recovery in medulloblastoma survivors. If we find that metformin promotes cognitive improvement and brain growth in paediatric survivors of medulloblastoma, this may offer a viable therapeutic approach that may improve quality of life of these cancer patients and provide a model for treatment of late effects in other paediatric cancers. This study is designed to test the efficacy of metformin in a 16-week multi-centre, phase III, double-blind, randomized placebo-controlled superiority trial with two parallel conditions (metformin versus placebo). Participants will be randomly assigned to one of the two treatments where they will either complete a 16-week cycle of metformin or a 16-week cycle of placebo. Participants will be randomized using Research Electronic Data Capture (REDCap) to ensure allocation concealment. The randomization code will not be released until the participant has been recruited, consented and passed screening. Outcome assessments will be conducted at Baseline (intelligence quotient (IQ) testing will also be conducted at Screening), immediately following the completion of week 16 treatment (Post-Intervention, Week 17), and 24 weeks following completion of the intervention (6 Month Follow-Up, Week 41). The primary endpoint is cognitive function in children/adolescent survivors of medulloblastoma at Post-Intervention (Week 17) compared to Baseline (Week 1). We hypothesize that 16 weeks of treatment with metformin will be associated with better cognitive outcomes than 16 weeks of treatment with placebo. Cognitive outcomes will be measured using tests of working memory, declarative memory, and processing speed. The key secondary outcome will be diffusion MRI within the corpus callosum at Post-Intervention (Week 17) compared to Baseline (Week 1). We hypothesize that 16 weeks of treatment with metformin will be associated with increased white matter growth in the corpus callosum compared to 16 weeks of treatment with placebo. Increased white matter growth will be measured using diffusion MRI metrics. Exploratory outcomes have been selected to investigate broader metformin-induced changes in the brain and cognition. We hypothesize that 16 weeks of treatment with metformin will promote global white matter growth in the brain more so than 16 weeks of treatment with placebo at Post-Intervention (Week 17) compared to Baseline (Week 1). White matter growth will be assessed using diffusion MRI metrics of myelin and fiber structure. We hypothesize that 16 weeks of treatment with metformin will result in greater increases in hippocampal volume compared to that 16 weeks of treatment with placebo at Post-Intervention (Week 17) compared to Baseline (Week 1). Structural MRI measures of hippocampal volume will be explored. We hypothesize that 16 weeks of treatment with metformin will result in superior performance on measures of attention, executive functioning, and intelligence compared to 16 weeks of treatment with placebo at Post-Intervention (Week 17) compared to Baseline (Week 1). Tests of attention, executive functioning, and intelligence will be used. We hypothesize that all outcome measures will continue in the predicted direction at 24 weeks (6 Month Follow-Up, Week 41) compared to Baseline (Week 1)/ screening (Day 0) following completion of 16 weeks of metformin compared to 16 weeks of placebo. We also hypothesize that 16 weeks of treatment with metformin will yield better outcomes in females compared to males for all measures and that these findings will persist at 24 weeks (6 Month Follow-Up, Week 41) following the intervention compared to Baseline (Week 1). We hypothesize that 16 weeks of treatment with metformin will result in improved ratings of global health as reported by the parent/guardian at Post-Intervention (Week 17) compared to Baseline (Week 1). Metformin is a well-studied medication with a broad clinical experience in children including polycystic ovarian syndrome, diabetes, and obesity. The youngest age of use is 2 years old. The proposed dose and the schedule of administration of metformin is based on safety and toxicity data obtained from our pilot trial and previous use in paediatric populations. One hundred and twenty (120) English speaking and twenty (20) French speaking participants - aged 7 years to 17 years and 11 months - will be recruited from up to 19 sites across Canada and Australia. Analysis of covariance (ANCOVA) will be used to examine the effects metformin versus placebo for each outcome in English speaking participants, controlling for Baseline outcome measurements. For French speaking participants, IQ testing will be completed, but not Cognitive testing as French-Canadian translations are not available. Results from IQ testing will be examined to explore the effects metformin versus placebo controlling for Screening visit outcome measurements. By focusing on a disease that requires some of the most aggressive therapy used in modern protocols, and by targeting the patients most vulnerable to the harmful effects of treatment we hope to provide a model of intervention that can then be applied to other cancers and actively promote brain health and cognitive recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma, Childhood, Cognitive Impairment
Keywords
Metformin, Paediatric brain tumour, Memory, Cognitive late effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
We elect to employ a parallel arm superiority trial. As there is no standard of care equivalent for the intervention being investigated (i.e. metformin for improved cognition and white matter growth), a placebo is being used to prevent any potential response bias.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
We are implementing a double-blind procedure to ensure that neither participants nor members of the research team have knowledge of the randomized treatment group to prevent bias in reporting, outcome assessment and analysis.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Oral metformin will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).
Intervention Type
Drug
Intervention Name(s)
Metformin hydrochloride (HCl) 500mg tablet
Other Intervention Name(s)
Glucophage
Intervention Description
Metformin HCl 500mg tablets contain 500mg of active pharmaceutical ingredient (API) and are white, round, biconvex, film-coated tablets, with a score line on one face and debossed with "HMR" on the other. Each tablet contains the non-medicinal ingredients magnesium stearate and povidone. Tablet coating is comprised of hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.
Primary Outcome Measure Information:
Title
Change from Week 1 (Baseline) Children's Auditory Verbal Learning Test-2 (CAVLT-2)/Rey Auditory Verbal Learning Test (RAVLT) Immediate Recall at Week 17 (Post-Intervention) to Assess Declarative Memory
Description
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for improving cognition, as measured by CAVLT-2/RAVLT which is a test of auditory verbal learning and memory.
Time Frame
Week 1 (Baseline), Week 17 (Post-Intervention)
Title
Change from Week 1 (Baseline) NIH Toolbox List Sort Working Working Memory Test at Week 17 (Post-Intervention) to Assess Working Memory
Description
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for improving cognition, as measured by List Sorting Working Memory Test (LSWMT) in which participants will be required to recall and place in sequence stimuli that are presented visually and verbally.
Time Frame
Week 1 (Baseline), Week 17 (Post-Intervention)
Title
Change from Week 1 (Baseline) Cambridge Neuropsychological Test Automated Battery (CANTAB) Mean Reaction Time for Correct Trials across the RVP, RTI, MTS, and DMS Subtests at Week 17 (Post-Intervention) to Assess Processing Speed
Description
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for improving cognition, as measured by mean reaction time for correct trials across subtests of the CANTAB: Rapid Visual Information Processing (RVP) Reaction Time (RTI) Match to Sample Visual Search (MTS) Delayed Matching to Sample (DMS) Each subtest provides an outcome measure of response latency, which will be averaged across all correct trials for each subtest to provide an overall measure of processing speed.
Time Frame
Week 1 (Baseline), Week 17 (Post-Intervention)
Secondary Outcome Measure Information:
Title
Diffusion Kurtosis Imaging (DKI) to Assess White Matter Growth within the Corpus Callosum
Description
To examine the effectiveness of 16 weeks of treatment with metformin versus 16 weeks of placebo for promoting white matter growth within the corpus callosum as measured by DKI including axonal water fraction (AWF), a metric sensitive to myelin.
Time Frame
Week 1 (Baseline), Week 17 (Post-Intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: No less than 3 weeks after completion of primary therapy for medulloblastoma Age 7 years to 17 years and 11 months at the time of enrollment Either declare English (or French in accepting sites) as their native language or have had at least two years of schooling in English (or French in accepting sites) at the time of consent Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen Meet criteria for normal organ function requirements as described below: Normal renal function defined as: Estimated glomerular filtration rate (eGFR) > 75ml/min/1.73m² eGFR is calculated using the Schwartz formula: eGFR (mL/min/1.73m²) = (0.41 × height in cm) / creatinine in mg/dL Normal liver function defined as: Serum glutamic-oxaloacetic transaminase (SGOT) (AST) <1.5 institutional upper limit of normal (ULN) for age and gender Serum glutamic pyruvic transaminase (SGPT) (ALT) <1.5 institutional ULN for age and gender Total bilirubin <1.5 institutional ULN for age and gender Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardian(s) by study team members delegated to consent for this study Exclusion Criteria: Participants who meet any of the following criteria will not be eligible to take part in the trial: Unable to participate in MRI without sedation Standard score of less than 60 for full scale IQ on the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) (for English speaking participants) or pro-rated IQ score on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) (for French speaking participants) at Screening visit Have a known hypersensitivity to metformin hydrochloride Have unstable and/or insulin-dependent (Type 1) diabetes Have a history of hypoglycemia after 2 years of age Have been diagnosed with acute or chronic metabolic acidosis and/or lactic acidosis or have a lactate level greater than 5 mmol/L at the Screening visit Have a history of renal disease or renal dysfunction Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry Currently taking part in a cognitive rehabilitation intervention study Treatment or planned treatment involving diuretics Current or planned treatment with cationic drugs excreted by the kidneys (e.g. amiloride, cimetidine, digoxin, morphine, nifedipine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) Current or planned treatment with concomitant medications with potential unacceptable interaction with metformin including topiramate, lamotrigine, levetiracetam, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, glycopyrrolate, and carbonic anhydrase inhibitors, or at the discretion of the Site PI or delegate for medications with potential interactions such as sertraline, lansoprazole and omeprazole. Pernicious anemia (according to results of the Screening visit blood draw) Current use of metformin hydrochloride Any condition or diagnosis, that could in the opinion of the Site PI or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia de Medeiros, M.Sc.
Phone
416-813-7396
Ext
307396
Email
cynthia.demedeiros@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Mabbott, Ph.D.
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eric Bouffet, M.D.
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Hunter Children's Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Alvaro, MMBS
Phone
+612 4985 5612
Email
frank.alvaro@health.nsw.gov.au
Facility Name
Children's Hospital in Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinisha Govender, MBBS
Phone
+612 9845 0925
Email
dinisha.govender@health.nsw.gov.au
Facility Name
Monash Children's Hospital
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Wood, MBBS
Phone
+613 8572 3490
Email
paul.wood@monashhealth.org
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Williams, MBBS
Phone
+613 9345 9184
Email
molly.wiliams@rch.org.au
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
West Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh Valvi, MBBS
Phone
+618 6456 3612
Email
santosh.valvi@health.wa.gov.au
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Lafay-Cousin, MD
Phone
403-955-2554
Email
lucie.lafay-cousin@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Sherry Qian
Phone
403-955-7263
Email
Sherry.Qian@AlbertaHealthServices.ca
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beverly Wilson, MD
Phone
780-407-8798
Email
bev.wilson@albertahealthservices.ca
Facility Name
Children's & Women's Health Centre of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette Hukin, MD
Phone
604-875-2406
Email
jhukin@cw.bc.ca
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magimairajan I Vanan, MD
Phone
204-787-4724
Email
mivanan@cancercare.mb.ca
Facility Name
Izaak Walton Killam (IWK) Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Erker, MD
Phone
902-470-3743
Email
craig.erker@iwk.nshealth.ca
Facility Name
Hamilton Health Sciences - McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Fleming, MD
Phone
905-521-2100
Ext
76720
Email
afleming@mcmaster.ca
Facility Name
Children's Hospital, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shayna Zelcer, MD
Phone
519-685-8500
Ext
52678
Email
Shayna.Zelcer@lhsc.on.ca
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Johnston, MD
Phone
613-737-7600
Ext
2210
Email
djohnston@cheo.on.ca
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Ramaswamy, MD
Phone
416-813-7654
Ext
208221
Email
vijay.ramaswamy@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Cynthia de Mederios, MSc
Phone
416-813-7396
Ext
307396
Email
cynthia.demedeiros@sickkids.ca
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Perreault, MD
Phone
514-345-4931
Ext
5019
Email
s.perreault@umontreal.ca
Facility Name
Montreal Children's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geneviève Legault, MD
Phone
514-412-4445
Email
genevieve.legault4@mcgill.ca
Facility Name
CHU de Québec - Université Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Larouche, MD
Phone
418-525-4444
Ext
40121
Email
valerie.larouche.med@ssss.gouv.qc.ca
Facility Name
CHU de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Vairy, MD
Phone
819-346-1110
Ext
7-3068
Email
Stephanie.Vairy@USherbrooke.ca
Facility Name
Saskatchewan Health Authority
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Felton, MD
Phone
306-655-2733
Email
Kathleen.Felton@saskhealthauthority.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

We'll reach out to this number within 24 hrs