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Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60

NCT02234037 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-01-30

No results posted yet for this study

Summary

STUDY BACKGROUND AND PURPOSE:

Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more common with increasing age. AML is harder to treat in older patients, with typically poor responses to standard chemotherapy.

Patients with AML are typically given intensive induction chemotherapy, but many older patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be active and better tolerated in frail patients with AML; however, most patients still relapse.

Recent studies suggest that improving the performance status and fitness of older AML patients prior to induction chemotherapy may help to lessen side effects.

This study will test the combination of decitabine treatment with physical exercise in elderly patients with AML who are not candidates for standard induction chemotherapy.

STUDY DESCRIPTION:

This is a pilot study to test the combination of decitabine treatment with an 8-week physical exercise program in AML patients ≥ 60 years of age who are not candidates for standard induction chemotherapy. Patients who are eligible to take part must give their written agreement before they can be enrolled.

This study will enroll 20 patients who are not candidates for standard induction chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3 sessions per week supervised by a physical therapist. During this 8-week period, patients will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a 28-day cycle).

Patients will be followed to assess the safety and tolerability of the program. Patients will also give blood samples that will be used to assess their response to treatment. Patients will be evaluated for their physical fitness before and after the 8-week exercise program and will complete questionnaires to assess their quality of life before and after the program.

Conditions

Interventions

DRUG

Decitabine

Decitabine will be administered intravenously at dose of 20mg/m² on 5 consecutive days every 28 days (1 cycle = 28 days) for a total of 2 cycles according to standard practice. Cycle 2 will proceed on time despite cytopenias, given that patients are not expected to be in remission after only 1 cycle of decitabine.

BEHAVIORAL

Exercise

Each patient will participate in 2-3 exercise sessions per week supervised by a physical therapist. Each exercise session will comprise \> 10 minutes of muscle strengthening, \> 10 minutes of aerobic exercise (treadmill walking or cycling), \> 10 minutes of stretching/range of motion exercises, and up to 10 minutes of individualized functional exercise (determined based on patient's reported deficits/targets in activities of daily living).

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Martha L Arellano, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-02-29
Completion
2016-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02234037 on ClinicalTrials.gov