Glucose Variability in Cancer Patients Receiving Dexamethasone

NCT02372539 | Withdrawn DMC

• 1 other identifier: 14-1764.cc
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Cancer

Keywords

dexamethasone

Outcome Measures

Primary Outcomes (1)

• Hyperglycemic potential of dexamethasone

  Determine the hyperglycemic potential associated with dexamethasone in cancer patients with and without diabetes.

  7 days

Secondary Outcomes (5)

• Measures of glucose variability

  7 days

• Time in hyperglycemia

  7 days

• Hyperglycemia impact

  7 days

• Risk factors for hyperglycemia

  7 days

• Comparison of insulin versus oral antihyperglycemic medications

  7 days

Study Arms (2)

Non-diabetes

Patients without diabetes will serve as the control group

Other: Control Group

Diabetes

Patients with diabetes will be further stratified based upon antihyperglycemic medications (insulin versus oral medications)

Other: Diabetes

Interventions

Diabetes OTHER

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

Diabetes

Control Group OTHER

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

Non-diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Society of Health-System Pharmacists: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cindy O'Bryant, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: January 1, 2015
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

US (1)