HyperglycemiaNCT02372539
Glucose Variability in Cancer Patients Receiving Dexamethasone
An observational study of Hyperglycemia and Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperglycemia, Cancer
- What is being tested?
- Diabetes
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with and without diabetes who are receiving intermittent high dose dexamethasone for prevention of chemotherapy-induced nausea and vomiting
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
- Conditions
- Hyperglycemia, Cancer
- Being tested
- Diabetes, Control Group
- Keywords
- dexamethasone
- Medical subject headings
- Hyperglycemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiabetesOther
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
Control GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetes | Patients without diabetes will serve as the control group Receives: Other: Control Group | |
| Diabetes | Patients with diabetes will be further stratified based upon antihyperglycemic medications (insulin versus oral medications) Receives: Other: Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycemic potential of dexamethasone
Determine the hyperglycemic potential associated with dexamethasone in cancer patients with and without diabetes.
Measured: 7 days
Secondary outcomes (5)
Measures of glucose variability
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
Measured: 7 days
Time in hyperglycemia
Evaluate the time spent in hyperglycemic ranges (>180mg/dl) related to the time of dexamethasone administration
Measured: 7 days
Hyperglycemia impact
Evaluate the impact of hyperglycemia on differences in clinical outcomes including patient reported adverse events and the incidence of those requiring medical intervention
Measured: 7 days
Risk factors for hyperglycemia
Evaluate participant baseline characteristics to determine if risk factors for blood glucose elevations can be identified
Measured: 7 days
Comparison of insulin versus oral antihyperglycemic medications
Evaluate if diabetes patients on oral medications versus insulin therapy demonstrate differences in blood glucose variability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Why it stopped: COVID prevented accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists
- Responsible party
- Sponsor
- Investigators
- Cindy O'Bryant, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372539
- Sponsor's protocol ID
- 14-1764.cc
- Status last verified
- Apr 2021
- First submitted
- 20 Feb 2015
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone
- ClinicalTrials.gov ID
- NCT02372539
- Acronym / sponsor ID
- 14-1764.cc
- Conditions
- Hyperglycemia, Cancer
- Keywords
- dexamethasone
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID prevented accruals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists
- Study start
- Jan 2015 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetes | – | Other: Control GroupPatients without diabetes will serve as the control group |
| Diabetes | – | Other: DiabetesPatients with diabetes will be further stratified based upon antihyperglycemic medications (insulin versus oral medications) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with and without diabetes who are receiving intermittent high dose dexamethasone for prevention of chemotherapy-induced nausea and vomiting
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiabetesAll 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 | Other | Diabetes |
| Control GroupAll 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 | Other | Non-diabetes |
Primary outcome
Hyperglycemic potential of dexamethasone
Time frame: 7 days
Determine the hyperglycemic potential associated with dexamethasone in cancer patients with and without diabetes.
5 secondary outcomes
Measures of glucose variability
Time frame: 7 days
Time in hyperglycemia
Time frame: 7 days
Hyperglycemia impact
Time frame: 7 days
Risk factors for hyperglycemia
Time frame: 7 days
Comparison of insulin versus oral antihyperglycemic medications
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy O'Bryant, PharmD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperglycemic potential of dexamethasone (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.