Glucose Variability in Cancer Patients Receiving Dexamethasone

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02372539
• Other study ID #: 14-1764.cc
• Status: Withdrawn
• Start date: January 2015
• Est. completion date: October 30, 2020

Study information

• Verified date: April 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• non-pregnant adult patients
• between 18-75 years of age
• 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

Related Conditions & MeSH terms

• Cancer
• Hyperglycemia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Society of Health-System Pharmacists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperglycemic potential of dexamethasone	Determine the hyperglycemic potential associated with dexamethasone in cancer patients with and without diabetes.	7 days
Secondary	Measures of glucose variability	Evaluate measures of glucose variability including SD, percent coefficient of variance (%CV), high blood glucose index, and mean amplitude of glucose excursions (MAGE) in cancer patients receiving high dose dexamethasone for CINV prophylaxis	7 days
Secondary	Time in hyperglycemia	Evaluate the time spent in hyperglycemic ranges (>180mg/dl) related to the time of dexamethasone administration	7 days
Secondary	Hyperglycemia impact	Evaluate the impact of hyperglycemia on differences in clinical outcomes including patient reported adverse events and the incidence of those requiring medical intervention	7 days
Secondary	Risk factors for hyperglycemia	Evaluate participant baseline characteristics to determine if risk factors for blood glucose elevations can be identified	7 days
Secondary	Comparison of insulin versus oral antihyperglycemic medications	Evaluate if diabetes patients on oral medications versus insulin therapy demonstrate differences in blood glucose variability	7 days