Aurora, Colorado 80045


Purpose:

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.


Criteria:

Inclusion Criteria: - non-pregnant adult patients between 18-75 years of age who are seen in the UCH outpatient cancer clinics for management of solid tumor and/or non-leukemia malignancies - are prescribed high dose dexamethasone for CINV for no longer than 5 days, and have an absolute neutrophil count (ANC) > 1,500/mm3 and platelet count > 100,000/mm3 at time of glucose sensor placement. ANC of 1,500/mm3 is standard criteria for receiving outpatient chemotherapy. Exclusion Criteria: - leukemia-type malignancy - require inpatient administration of chemotherapy - are receiving chronic steroids - have an ECOG/WHO/Zubrod score of 3 or 4 - have an ANC < 1,500 cells/mm3 at time of CGM device placement or are anticipated to have a decrease in ANC < 1,500 cells/mm3 during 5 days after sensor placement, - have an active infection, or have significant cognitive impairment limiting their ability to use the CGM or complete a take-home diary. - to further minimize the potential for infection, patients receiving chemotherapy regimens associated with a high (>20%) risk of febrile neutropenia, according to the 2014 NCCN guidelines, will also be excluded from study


NCT ID:

NCT02372539


Primary Contact:

Principal Investigator
Cindy O'Bryant, PharmD
University of Colorado - Anschutz Medical Campus

Cindy O'Bryant, PharmD
Phone: 303-724-2625
Email: cindy.obryant@ucdenver.edu


Backup Contact:

Email: sam.ellis@ucdenver.edu
Sam Ellis, PharmD
Phone: 303-724-2616


Location Contact:

Aurora, Colorado 80045
United States

Cindy O'Bryant, PharmD
Phone: 303-724-2625
Email: cindy.obryant@ucdenver.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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