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Completed

NCT Number: NCT01869777

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

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.

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Key information

Conditions

Acute Undifferentiated Leukemia Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Biphenotypic, Acute Leukemia, Lymphoid Leukemia, Mast-Cell Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Mast Cell Activation Disorders Mast Cell Leukemia Mastocytosis Mastocytosis, Systemic Myeloid/NK-cell Acute Leukemia Neoplasms Neoplasms by Histologic Type Untreated Adult Acute Lymphoblastic Leukemia Untreated Adult Acute Myeloid Leukemia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioelectric Impedance Analysis

Procedure

Undergo bioelectric impedance analysis

Other names: BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis

Primary outcomes

  1. 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

  1. 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. 30 day mortality rate is defined as the percent of patients no longer alive at 30 days after registration.

  2. 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.

  3. Number of Participants Transferred 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.

  4. Number of Participants With Bone Marrow Response

    Time frame: 14 days

    Logistic regression will be used to analyze the significant association between standardized phase angle and marrow response at 14-day bone marrow biopsy to show the odds of having 14-day residual disease (presence cancer cells remaining after treatment) and non-residual disease (no cancer cells remaining after treatment). (14 day bone marrow response is defined as hypoplastic marrow with less than 20% cellularity and 5% blasts. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count >1000, platelet count >100,000 and freedom from red cell transfusions).

  5. Number of Participants to Achieve Complete Remission

    Time frame: Up to 2 years

    Logistic regression will be used to analyze the association between standardized phase angle and complete remission. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count > 1000, platelet count > 100,000 and freedom from red cell transfusions

  6. Number of Participants With 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Newly Diagnosed Acute Leukemia

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Jun 5, 2013
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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