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Glycemic Impact on Glioblastoma Outcomes

Study Purpose

This pilot study aims to evaluate the feasibility of close glucose monitoring and management of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized based on individual blood glucose levels. Although the glycemic interventions used in this study include standard medications and methods of glucose monitoring used for patients with diabetes, this pilot study will specifically evaluate the feasibility of using these approaches in patients with GBM, appreciating their additional medical, functional and social challenges.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients (> 18 years old) with a new histologically-confirmed diagnosis of glioblastoma who are planned to receive a 6-week course of concurrent radiation and temozolomide.

- Has evidence of random glucose of at least 7.8 mmol/L or fasting blood glucose of at least 6.1 mmol/L (meeting criteria for oral diabetic medications) - Able to provide informed consent.

- Able to understand and follow instructions regarding self-administered capillary glucose measurements.

Exclusion Criteria:

- Contraindication to MRI with gadolinium.

- Taking anti-hyperglycemic medications at the time of study eligibility screen.

- Unable to participate in neurocognitive evaluation in English

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03235934
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Health Network, Toronto
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Withdrawn
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme, Hyperglycemia

Additional Details

The purpose of this pilot study is to determine the feasibility of using close monitoring and management of glucose levels in patients undergoing radiation and chemotherapy for glioblastoma. The glucose management will include the use of standard metformin a common treatment for patients with early type 2 diabetes that has also shown anti-tumor effects in GBM, and will be further personalized based on individual blood glucose levels. Additional anti-hyperglycemic management will be provided at the discretion of the Endocrinologist. Close glucose monitoring will include flash glucose monitoring (FGM) with a device called an FreeStyle Libre Pro Flash Glucose Monitoring System, finger-prick glucose measures (standard approach for patients with diabetes) and weekly blood tests (our current standard for patients with GBM). In addition to determining the feasibility of using these approaches, this pilot study will help identify the simplest and most effective approach of managing glucose levels in patients with GBM appreciating their additional medical, functional and social challenges.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

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