Clinical Trial: Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: INVESTIGATING THE PROGNOSTIC IMPORTANCE OF BIOELECTRICAL IMPEDANCE PHASE ANGLE IN ADULTS TREATED FOR NEWLY DIAGNOSED ACUTE LEUKEMIA

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 Summary:

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:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Treatment related mortality defined as the percent of patients no longer alive at 30 days after registration [ Time Frame: 30 days ]
    Logistic regression will be used to analyze the association between standardized phase angle and 30 day mortality.
  • Length of hospitalization [ Time Frame: Up to 2 years ]
    A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
  • Transfer to intensive care unit during induction [ Time Frame: Up to 2 years ]
    Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
  • Bone marrow response [ Time Frame: 14 days ]
    Logistic regression will be used to analyze the association between standardized phase angle and marrow response.
  • Complete remission defined as less than 5% marrow blasts, absolute neutrophil count > 1000, platelet count > 100,000 and freedom from red cell transfusions [ Time Frame: Up to 2 years ]
    Logistic regression will be used to analyze the association between standardized phase angle and complete remission.
  • Receipt of post-remission therapy [ Time Frame: Up to 2 years ]
    Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.
  • Overall survival [ Time Frame: Up to 2 years ]
    Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.


Original Secondary Outcome: Same as current

Information By: Wake Forest University Health Sciences

Dates:
Date Received: May 31, 2013
Date Started: July 2013
Date Completion:
Last Updated: January 17, 2017
Last Verified: November 2016