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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT02372539 |
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Date of registration:
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20/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Glucose Variability in Cancer Patients Receiving Dexamethasone
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Scientific title:
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Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02372539 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Cindy O'Bryant, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado - Anschutz Medical Campus |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cancer
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Hyperglycemia
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Intervention(s)
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Other: Control Group
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Other: Diabetes
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Primary Outcome(s)
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Hyperglycemic potential of dexamethasone
[Time Frame: 7 days]
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Secondary Outcome(s)
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Comparison of insulin versus oral antihyperglycemic medications
[Time Frame: 7 days]
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Measures of glucose variability
[Time Frame: 7 days]
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Time in hyperglycemia
[Time Frame: 7 days]
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Risk factors for hyperglycemia
[Time Frame: 7 days]
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Hyperglycemia impact
[Time Frame: 7 days]
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Secondary ID(s)
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14-1764.cc
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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