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A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy

Acute myeloid leukaemia (AML) is a life-threatening malignant blood disorder. Curative
treatment requires multiple cycles of intensive chemotherapy. The first cycle, induction, is
the most intense and intended to achieve complete disease remission (CR). Induction therapy
requires 4-6 weeks of inpatient admission and is associated with extended bed rest and
multiple toxicities, leading to physical deconditioning. Regular exercise during induction
may reduce declines in physical fitness, leading to improved quality of life (QOL), reduced
fatigue, improved tolerance of chemotherapy, and potentially greater survival. Four prior
studies of exercise in AML patients undergoing induction have suggested improvements in QOL,
fatigue, physical function, and treatment tolerability. However, all 4 studies suffered from
major limitations including small sample sizes, design limitations, generalizability
concerns, and limited safety information. The investigators conducted a pilot non-randomized
study in 35 AML patients and demonstrated feasibility, safety, and potential improvements in
QOL, fatigue, and physical fitness outcomes. The investigators now propose a rigorous
evaluation of the intervention in a phase II randomized controlled trial (RCT).

Primary objectives include: (1) To determine the efficacy of a supervised mixed-modality
exercise program during induction chemotherapy on QOL and fatigue; (2) To determine the
efficacy on physical fitness. Our secondary objective is to determine the efficacy on AML
treatment tolerability (hospital length of stay, development of sepsis, intensive care unit
(ICU) admission, delays in consolidation chemotherapy).

Inclusion Criteria:

- Is ≥ 18 years old

- Has newly diagnosed AML, or relapsed AML after having been in CR for at least 6

- Is initiating induction chemotherapy

- Is ambulatory without need for human assistance

- Has consented to study

- Is medically cleared for participation by the attending physician

Exclusion Criteria:

- Has another active malignancy

- Has life expectancy < 1 month, physician determined

- Has significant comorbidity

- Has uncontrolled pain

- Has haemodynamic instability

- Lacks fluency in reading and writing English, and there is no translator available
for each visit

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change from baseline in quality of life at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) (QOL)

Outcome Description:

EORTC QLQ-C30 (questionnaire)

Outcome Time Frame:

Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)

Safety Issue:


Principal Investigator

Shabbir Alibhai, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:

AML 003



Start Date:

June 2011

Completion Date:

September 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • chemotherapy
  • exercise
  • quality of life
  • cancer-related fatigue
  • elderly
  • physical fitness
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid