Clinical trial NCT03235934: Glycemic Impact on Glioblastoma Outcomes
Official title: Glycemic Impact on Glioblastoma Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Glioblastoma Multiforme
Hyperglycemia
Keywords: glucose monitoring
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sinai Health System
First posted: 2017-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who are newly diagnosed with glioblastoma

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Total time spent in target glucose level
timeFrame: 1 week
Secondary outcomes:
measure: Area under the curve for glycemic exposure and variability
timeFrame: baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months
measure: Neurocognitive Function
timeFrame: Baseline
measure: Neurocognitive Function
timeFrame: After week 10 and before week 13
measure: Neurocognitive Function
timeFrame: 3 month follow up visit
measure: prevalence of sensor site problems
timeFrame: From baseline to week 6 - the time from sensor insertion through completion of study intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: