Clinical trial NCT02372539: Glucose Variability in Cancer Patients Receiving Dexamethasone
Official title: Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hyperglycemia
Cancer
Keywords: dexamethasone
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Society of Health-System Pharmacists
First posted: 2015-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with and without diabetes who are receiving intermittent high dose dexamethasone for prevention of chemotherapy-induced nausea and vomiting

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hyperglycemic potential of dexamethasone
timeFrame: 7 days
Secondary outcomes:
measure: Measures of glucose variability
timeFrame: 7 days
measure: Time in hyperglycemia
timeFrame: 7 days
measure: Hyperglycemia impact
timeFrame: 7 days
measure: Risk factors for hyperglycemia
timeFrame: 7 days
measure: Comparison of insulin versus oral antihyperglycemic medications
timeFrame: 7 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cindy O'Bryant, PharmD
role: PRINCIPAL_INVESTIGATOR
References: