Glycemic Impact on Glioblastoma Outcomes

Glioblastoma Multiforme Clinical Trial

Official title:

Glycemic Impact on Glioblastoma Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03235934
• Other study ID #: 15-9329
• Status: Withdrawn
• Start date: December 1, 2018
• Est. completion date: January 24, 2020

Study information

• Verified date: October 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 24, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Hyperglycemia

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sinai Health System

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total time spent in target glucose level	total time spent in target range of 4-10 mmol/L based on FGM data during week 6 of radiotherapy and temozolomide therapy	1 week
Secondary	Area under the curve for glycemic exposure and variability	Glucose levels measured using FGM vs conventional clinical measures (e.g. capillary blood glucose)	baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months
Secondary	Neurocognitive Function	To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests	Baseline
Secondary	Neurocognitive Function	To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests	After week 10 and before week 13
Secondary	Neurocognitive Function	To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests	3 month follow up visit
Secondary	prevalence of sensor site problems	infection, irritation, and secondary complication in the study cohort	From baseline to week 6 - the time from sensor insertion through completion of study intervention