Glycemic Impact on Glioblastoma Outcomes

NCT03235934 | Withdrawn

• 1 other identifier: 15-9329
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme; Hyperglycemia

Keywords

glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Area under the curve for glycemic exposure and variability

  baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months

• Neurocognitive Function

  Baseline

• Neurocognitive Function

  After week 10 and before week 13

• Neurocognitive Function

  3 month follow up visit

• prevalence of sensor site problems

  From baseline to week 6 - the time from sensor insertion through completion of study intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are newly diagnosed with glioblastoma

You may qualify if:

• 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

You may not qualify if:

• Contraindication to MRI with gadolinium
• Taking anti-hyperglycemic medications at the time of study eligibility screen
• Unable to participate in neurocognitive evaluation in English

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sinai Health System: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Glioblastoma; Hyperglycemia

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: August 1, 2017
• Study Start: December 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: January 24, 2020
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)