An Exercise Trial for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

November 21, 2019 updated by: University Health Network, Toronto

A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy

Reduced quality of life, fatigue, and loss of physical function are common in patients getting chemotherapy for acute myeloid leukaemia (AML). The investigators completed a pilot study showing that exercise during active chemotherapy for AML is feasible, safe, and may improve symptoms and physical function. The investigators now propose to compare our hospital-based supervised exercise program to usual care to see if exercise can improve symptoms, physical function, and improve treatment tolerability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is ≥ 18 years old
  • Has newly diagnosed AML, or relapsed AML after having been in CR for at least 6 months
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Patients will receive an individualized, supervised mixed-modality exercise program created by a CSEP-Certified Exercise Physiologist (CEP).
Behavioral: Exercise
Patients will receive an individualized, supervised mixed-modality exercise program created by a CSEP-Certified Exercise Physiologist (CEP). They will perform 30 minutes of light to moderate intensity exercise 4-5 times/week tailored to ability. Aerobic exercise will primarily consist of walking and/or stationary cycling. Resistance exercises will target large muscle groups using dumbbells, resistance bands, and stability balls. The CEP will monitor and document details of each exercise session as well as patient tolerance and symptoms, and make appropriate adaptations to ensure program safety and progression. Exercise intensity and duration will vary based on patient tolerance, symptoms and blood parameters. Exercise equipment will be carefully sanitized between each use.
No Intervention: Control
Participants assigned to this arm will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) (QOL)
Time Frame: Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
EORTC QLQ-C30 (questionnaire)
Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
Change from baseline in fatigue at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)
Time Frame: Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
FACT-F (questionnaire)
Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
Change from baseline in fitness measures at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)
Time Frame: Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
The fitness assessment will encompass various measures to assess physical fitness. The following measures will be completed: VO2 peak (a measure of aerobic capacity), 6-minute walk test, grip strength and maximal leg strength, chair stands.
Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment tolerability
Time Frame: Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)
Length of stay (as an in-patient), development of sepsis (during induction chemotherapy), ICU admission (during induction chemotherapy), delay in consolidation chemotherapy.
Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Shabbir Alibhai, MD, MSc, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 4, 2011

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML 003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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