Glucose Variability in Cancer Patients Receiving Dexamethasone

University of Colorado Denver (CU Denver)

Status

Withdrawn

Conditions

Hyperglycemia

Cancer

Treatments

Other: Control Group

Other: Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT02372539

14-1764.cc

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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