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临床试验/NCT02372539
NCT02372539撤回不适用

Pilot Project to Evaluate Hyperglycemia and Glucose Variability in Cancer Patients Receiving Dexamethasone

University of Colorado, Denver1 个研究点 分布在 1 个国家开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Hyperglycemic potential of dexamethasone

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Hyperglycemic potential of dexamethasone

时间窗: 7 days

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

次要结局

  • Hyperglycemia impact(7 days)
  • Measures of glucose variability(7 days)
  • Risk factors for hyperglycemia(7 days)
  • Comparison of insulin versus oral antihyperglycemic medications(7 days)
  • Time in hyperglycemia(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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