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)
• Enrollment: 102
• Location: 1
• Arm: 1
• Actual Duration (Months): 82
• Patients Per Site Per Month: 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.

Condition or Disease	Intervention/Treatment	Phase
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); Mast Cell Leukemia; Myeloid/NK-cell Acute Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia	Procedure: bioelectric impedance analysis	N/A

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)

• Study Protocol and Statistical Analysis Plan - Jul 25, 2014
• Informed Consent Form - Aug 21, 2018

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: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Mast-Cell; Acute Disease

Study Results

Participant Flow

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.