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Glucose Variability in Cancer Patients Receiving Dexamethasone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372539
Recruitment Status : Recruiting
First Posted : February 26, 2015
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
American Society of Health-System Pharmacists
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment
Hyperglycemia Cancer Other: Diabetes Other: Control Group

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone
Study Start Date : January 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non-diabetes
Patients without diabetes will serve as the control group
Other: Control Group
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
Patients with diabetes will be further stratified based upon antihyperglycemic medications (insulin versus oral medications)
Other: Diabetes
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




Primary Outcome Measures :
  1. Hyperglycemic potential of dexamethasone [ Time Frame: 7 days ]
    Determine the hyperglycemic potential associated with dexamethasone in cancer patients with and without diabetes.


Secondary Outcome Measures :
  1. Measures of glucose variability [ Time Frame: 7 days ]
    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

  2. Time in hyperglycemia [ Time Frame: 7 days ]
    Evaluate the time spent in hyperglycemic ranges (>180mg/dl) related to the time of dexamethasone administration

  3. Hyperglycemia impact [ Time Frame: 7 days ]
    Evaluate the impact of hyperglycemia on differences in clinical outcomes including patient reported adverse events and the incidence of those requiring medical intervention

  4. Risk factors for hyperglycemia [ Time Frame: 7 days ]
    Evaluate participant baseline characteristics to determine if risk factors for blood glucose elevations can be identified

  5. Comparison of insulin versus oral antihyperglycemic medications [ Time Frame: 7 days ]
    Evaluate if diabetes patients on oral medications versus insulin therapy demonstrate differences in blood glucose variability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372539


Contacts
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Contact: Cindy O'Bryant, PharmD 303-724-2625 cindy.obryant@ucdenver.edu
Contact: Sam Ellis, PharmD 303-724-2616 sam.ellis@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Cindy O'Bryant, PharmD    303-724-2625    cindy.obryant@ucdenver.edu   
Contact: Samuel Ellis, PharmD    303-7242616    sam.ellis@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
American Society of Health-System Pharmacists
Investigators
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Principal Investigator: Cindy O'Bryant, PharmD University of Colorado - Anschutz Medical Campus
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02372539    
Other Study ID Numbers: 14-1764.cc
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Colorado, Denver:
dexamethasone
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases