Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Newly Diagnosed Acute Leukemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
Study Overview
Brief Summary
This clinical trial studies bioelectrical impedance measurement for predicting treatment outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as bioelectrical impedance measurement, may help predict a patient's response to treatment for acute leukemia.
Detailed Description
PRIMARY OBJECTIVES:
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.
OUTLINE:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalized for newly diagnosed acute leukemia
- •Receiving induction treatment while hospitalized
- •Willing and able to provide written informed consent
Exclusion Criteria
- •Presence of a pacemaker or defibrillator
- •Patients pregnant at the time of enrollment
- •Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
- •Unable/unwilling to follow protocol requirements
Arms & Interventions
Diagnostic (bioelectric impedance analysis)
Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.).
Intervention: bioelectric impedance analysis (Procedure)
Outcomes
Primary Outcomes
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
Time Frame: 60 days
Logistic regression will be used to analyze the association between standardized phase angle and 60 day mortality. 60 day mortality rate is defined as the percent of patients no longer alive at 60 days after registration. Patients that are discharged to hospice care before 60 days without a known date of death will be counted towards 60 day mortality
Secondary Outcomes
- Overall Survival(Up to 2 years)
- Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration(30 days)
- Length of Hospitalization(Up to 2 years)
- Number of Participants Transferred to Intensive Care Unit During Induction(Up to 2 years)
- Number of Participants With Bone Marrow Response(14 days)
- Number of Participants to Achieve Complete Remission(Up to 2 years)
- Number of Participants With Receipt of Post-Remission Therapy(Up to 2 years)