Glucose Variability in Cancer Patients Receiving Dexamethasone



Status:Recruiting
Conditions:Cancer, Cancer, Diabetes
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - 75
Updated:12/29/2018
Start Date:January 2015
End Date:December 2019
Contact:Cindy O'Bryant, PharmD
Email:cindy.obryant@ucdenver.edu
Phone:303-724-2625

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

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.


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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Phone: 303-724-2625
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Aurora, CO
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