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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01869777
Collaborator
National Cancer Institute (NCI) (NIH)
102
1
1
82
1.2

Study Details

Study Description

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.

  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Newly Diagnosed Acute Leukemia
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Mar 19, 2018
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.).

Procedure: bioelectric impedance analysis
Undergo bioelectric impedance analysis
Other Names:
  • BIA
  • bioelectric impedance
  • bioelectric impedance test
  • bioimpedance analysis
  • Outcome Measures

    Primary Outcome Measures

    1. Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration [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 Outcome Measures

    1. Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration [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 [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 [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 [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 [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 [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 [Up to 2 years]

      Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Timothy Pardee, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01869777
    Other Study ID Numbers:
    • IRB00023374
    • NCI-2013-00964
    • P30CA012197
    • CCCWFU 99113
    First Posted:
    Jun 5, 2013
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Period Title: Overall Study
    STARTED 102
    COMPLETED 101
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Overall Participants 101
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    62.6
    Sex: Female, Male (Count of Participants)
    Female
    57
    56.4%
    Male
    44
    43.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    4%
    Not Hispanic or Latino
    97
    96%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    3
    3%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    7
    6.9%
    White
    91
    90.1%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    101
    100%

    Outcome Measures

    1. Primary Outcome
    Title Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
    Description 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
    Time Frame 60 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Alive
    91
    90.1%
    Deceased
    10
    9.9%
    2. Secondary Outcome
    Title Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration
    Description 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.
    Time Frame 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Alive
    95
    94.1%
    Deceased
    6
    5.9%
    3. Secondary Outcome
    Title Length of Hospitalization
    Description A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Mean (Standard Deviation) [Days]
    34.2
    (11.9)
    4. Secondary Outcome
    Title Number of Participants Transferred to Intensive Care Unit During Induction
    Description Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Transferred to ICU
    10
    9.9%
    Not transferred to ICU
    91
    90.1%
    5. Secondary Outcome
    Title Number of Participants With Bone Marrow Response
    Description 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).
    Time Frame 14 days

    Outcome Measure Data

    Analysis Population Description
    14 participants excluded in analysis due to 14-day bone marrow data not available.
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 87
    Residual disease
    47
    46.5%
    No residual disease
    40
    39.6%
    6. Secondary Outcome
    Title Number of Participants to Achieve Complete Remission
    Description 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
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Achieved complete remission
    81
    80.2%
    Did not achieve complete remission
    20
    19.8%
    7. Secondary Outcome
    Title Number of Participants With Receipt of Post-Remission Therapy
    Description Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Receipt of post-remission therapy
    79
    78.2%
    Did not receive post-remission therapy
    22
    21.8%
    8. Secondary Outcome
    Title Overall Survival
    Description Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    Measure Participants 101
    Median (95% Confidence Interval) [Days]
    532

    Adverse Events

    Time Frame Up to 2 years to assess for survival only
    Adverse Event Reporting Description Adverse events were not monitored/assessed for this trial.
    Arm/Group Title Diagnostic (Bioelectric Impedance Analysis)
    Arm/Group Description 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    All Cause Mortality
    Diagnostic (Bioelectric Impedance Analysis)
    Affected / at Risk (%) # Events
    Total 16/101 (15.8%)
    Serious Adverse Events
    Diagnostic (Bioelectric Impedance Analysis)
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Diagnostic (Bioelectric Impedance Analysis)
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Principal investigator
    Organization Wake Forest University Health Sciences
    Phone 336-716-5440
    Email tpardee@wakehealth.edu
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01869777
    Other Study ID Numbers:
    • IRB00023374
    • NCI-2013-00964
    • P30CA012197
    • CCCWFU 99113
    First Posted:
    Jun 5, 2013
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    May 1, 2020