Continuous Glucose Monitoring for the Prediction and Treatment of Steroid-Induced Hyperglycemia

Status: complete

This trial studies how well continuous glucose monitoring identifies very high glucose values in patients with breast cancer and pre-diabetes, medical obesity, or well-controlled diabetes undergoing chemotherapy. Steroid hormones, called glucocorticoids, are often given to breast cancer patients undergoing chemotherapy to fight inflammation and work with the immune system to treat various problems. However, these medications can increase glucose values and possibly lead to other health conditions, including high glucose levels (hyperglycemia). A continuous glucose monitor is a system that uses a sensor under the skin to monitor glucose levels at regular intervals, providing real-time, or near real-time, glucose information. This study may provide useful information about the importance of monitoring glucose values in patients receiving chemotherapy for breast cancer.

Inclusion Criteria

Patient aged 18 or older undergoing neoadjuvant chemotherapy regimens including taxane and/or anthracycline for breast cancer
Patient aged 18 or older undergoing any chemotherapy regimen for pancreatic cancer
Have high metabolic risk (either pre-diabetes, obesity, or well-controlled diabetes) defined as either: * Pre-diabetes and/or obesity group: one or more of HbA1c 5.7-6.5%, fasting glucose > 100 mg/dL, or BMI > 30 * Well-controlled diabetes: Known HbA1c < 7.5 on lifestyle alone or up to one oral antidiabetic agent * Any patient undergoing treatment for pancreatic adenocarcinoma on either no antidiabetic agent or up to one oral antidiabetic agent

Exclusion Criteria

Patients with type 1 diabetes, a history of hospitalization for either hyperglycemia or ketoacidosis, a history of hypoglycemia requiring hospitalization, rashes or other skin reactions that would preclude placement of the continuous glucose monitor (CGM)
Use of anticoagulants or antiplatelet agents other than aspirin
Platelet count < 50 K/uL

PRIMARY OBJECTIVE:

I. Identify prevalence of severe hyperglycemia (glucose > 400 mg/dL for over 3 contiguous hours) in metabolically high risk patients during chemotherapy.

PILOT AND EXPLORATORY OBJECTIVES:

I. Assess feasibility (defined as the ability to enroll the target population within one year with 80% of patients completing the study) and tolerability (defined as no more than 10% of patients develop Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5 grade 2 or higher event adverse events) of the study design.

II. Identify potential risk factors for severe hyperglycemia among metabolically high risk population (including body mass index [BMI], baseline glycosylated hemoglobin [HbA1c], and steroid dose).

III. Identify potential associations between severe hyperglycemia and outcomes of potential clinical significance.

OUTLINE:

Patients wear a continuous glucose monitoring system (CGM) for 14 days during the first and third cycles of neoadjuvant chemotherapy.

After completion of study, patients are followed up for 1 year.

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Continuous Glucose Monitoring for the Prediction and Treatment of Steroid-Induced Hyperglycemia

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