INVESTIGATING THE PROGNOSTIC IMPORTANCE OF BIOELECTRICAL IMPEDANCE PHASE ANGLE IN ADULTS TREATED FOR NEWLY DIAGNOSED ACUTE LEUKEMIA
I: To determine the feasibility of obtaining standardized phase angle measurements
(bioelectrical impedance measurement) on patients hospitalized for treatment of newly
diagnosed acute leukemia.
II. To evaluate the association between standardized phase angle measured at the start of
therapy and treatment-related outcomes including treatment related mortality (defined as
60-day mortality) III. Evaluate the association of the day 14 standardized phase angle and
treatment related outcomes, 30-day mortality, length of hospitalization, transfer to
intensive care unit during induction, treatment response (14 day bone marrow response,
complete remission), receipt of post-remission therapy, overall survival.
IV. An exploratory analysis investigating associations with the primary and secondary
outcomes using different ways to categorize the baseline standardized phase angle and, for
acute myeloid leukemia (AML) patients, the standardized phase angle measure obtained just
prior to the nadir marrow.
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment.
Patients with AML undergo a second measurement prior to the nadir marrow. Patients also
undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow
biopsy, leukapheresis, peripherally inserted central catheter [PICC] line placement, etc.).
After completion of study treatment, patients are followed up for two years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Treatment related mortality defined as the percent of patients no longer alive at 60 days after registration
Logistic regression will be used to analyze the association between standardized phase angle and 60 day mortality.
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|