NCT02372539

Glucose Variability in Cancer Patients Receiving Dexamethasone

Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Dexamethasone is a steroid commonly used for the prevention of chemotherapy-induced nausea and vomiting (CINV). While effective, high dose dexamethasone is associated with numerous side effects, even when used for a short duration. One such effect is elevated blood glucose, or hyperglycemia. Current literature suggests increased risk of infection, poor wound healing, and increased mortality in non-cancer surgical patients with steroid-induced hyperglycemia. There is also evidence to support that elevations in blood glucose are associated with worsened outcomes in cancer patients. Much of this data comes from cancer patients that are treated in an inpatient setting where blood glucose is routinely checked. Limited data is available describing the fluctuations in blood glucose following dexamethasone administration in cancer patients being managed in an outpatient setting, such as the Anschutz Cancer Pavilion (ACP) Infusion Clinic. This study aims to characterize the effects dexamethasone has on blood glucose in cancer patients by utilizing Continuous Glucose Monitoring (CGM) devices. These devices are minimally invasive, are FDA approved, and can produce real-time data of blood glucose fluctuations over a course of 3-7 days. By inserting the devices under the skin of the abdomen, the investigators can evaluate the temporal relationship between glucose abnormalities and dexamethasone administration. Results from this study will not only increase the knowledge base of dexamethasone-induced hyperglycemia and identify patients at increased risk, but also allow future research to be conducted in order to determine if standard protocols can proactively minimize steroid-induced glucose fluctuations.

Conditions

• Hyperglycemia
• Cancer

Interventions

Type	Name	Description
OTHER	Diabetes	All patients enrolled in study will be given dexamethasone for prophylaxis of chemotherapy-induced nausea and vomiting. This will already be a part of their chemotherapy regimen and will not be prescribed by study investigators
OTHER	Control Group	All patients enrolled in study will be given dexamethasone for prophylaxis of chemotherapy-induced nausea and vomiting. This will already be a part of their chemotherapy regimen and will not be prescribed by study investigators

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2015-02-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: United States