This study evaluates how blood sugar changes during chemotherapy using a continuous blood sugar monitoring device, Freestyle Libre Pro, in patients with stages I-III breast cancer. The FreeStyle Libre monitors interstitial glucose via disposable subcutaneous sensor filaments adhered to the skin without requiring a finger or skin prick. The subcutaneous sensor is placed by a single-use applicator, and automatically measures glucose every 15 minutes for up to 14 days without the need for calibration with self-monitored blood glucose. A wireless scan of the sensor by the reader collects the glucose data. This study may help researchers learn how Freestyle Libre Pro may help monitor blood sugar changes during chemotherapy in patients with stages I-III breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04473378.
PRIMARY OBJECTIVES:
I. To determine the prevalence of hyperglycemia (HG) in participants with early stage breast cancer (BC) during chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate prevalence of impaired glucose tolerance, defined as a hemoglobin a1c > 5.7% at baseline in nondiabetic patients.
II. To evaluate changes from baseline in hemoglobin a1c, fasting glucose, and fasting insulin levels at week 12 and week 24 after initiation of neoadjuvant/adjuvant chemotherapy.
III. To evaluate changes from baseline in fructosamine and serum creatinine every 3 weeks during chemotherapy and at week 24 after initiation of neoadjuvant/adjuvant chemotherapy.
IV. To evaluate changes from baseline in body mass index and waist circumference at week 12 and week 24 after initiation of neoadjuvant/adjuvant chemotherapy.
V. To evaluate changes from baseline in patient reported outcomes of chemotherapy induced peripheral neuropathy (European Organization for Research and Treatment of Cancer [EORTC]-Chemotherapy-Induced Peripheral Neuropathy [CIPN] 20), quality of life (Patient Reported Outcomes Measurement Information System [PROMIS]-29), and fatigue (Brief Fatigue Inventory [BFI]) at week 12 and week 24 after initiation of neoadjuvant/adjuvant chemotherapy.
TERTIARY OBJECTIVES:
I. To explore patient-related factors associated with hyperglycemia development.
OUTLINE: This is an observational study.
Participants wear Freestyle Libre Pro through completion of chemotherapy and complete questionnaires on study. Participants also undergo collection of blood samples on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorMelissa K. Accordino
