Glucose Variability in Cancer Patients Receiving Dexamethasone

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperglycemia, Cancer

Intervention / Treatment
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* Other: Diabetes
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-diabetes<br>Patients without diabetes will serve as the control group | Other: Control Group<br>* 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<br>|
| Diabetes<br>Patients with diabetes will be further stratified based upon antihyperglycemic medications (insulin versus oral medications) | Other: Diabetes<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperglycemic potential of dexamethasone | Determine the hyperglycemic potential associated with dexamethasone in cancer patients with and without diabetes. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time in hyperglycemia | Evaluate the time spent in hyperglycemic ranges (>180mg/dl) related to the time of dexamethasone administration | 7 days | 
| 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 | 
| Risk factors for hyperglycemia | Evaluate participant baseline characteristics to determine if risk factors for blood glucose elevations can be identified | 7 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone