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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01446081
First received: August 4, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Behavioral: Exercise
Behavioral: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    EORTC QLQ-C30 (questionnaire)

  • 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) ] [ Designated as safety issue: No ]
    FACT-F (questionnaire)

  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Treatment tolerability [ Time Frame: Post-induction (weeks 4-6), Post-consolidation (weeks 10-12) ] [ Designated as safety issue: No ]
    Length of stay (as an in-patient), development of sepsis (during induction chemotherapy), ICU admission (during induction chemotherapy), delay in consolidation chemotherapy.


Estimated Enrollment: 75
Study Start Date: June 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise 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 Behavioral: Control
Participants assigned to the control group will receive usual care, which typically consists of recommendations to be physically active each day. Control group participants will be provided with exercise equipment and instructions following visit 2 (post-induction).

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446081

Contacts
Contact: Shabbir Alibhai, MD, MSc 416-340-5125 shabbir.alibhai@uhn.on.ca
Contact: Sara O'Neill, MSc 416-597-3422 ext 7860 soneill@uhnresearch.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Sara O'Neill, MSc    416-597-3422 ext 7860    soneill@uhnresearch.ca   
Principal Investigator: Shabbir Alibhai, MD, MSc         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Shabbir Alibhai, MD, MSc University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Shabbir Alibhai, University Health Network
ClinicalTrials.gov Identifier: NCT01446081     History of Changes
Other Study ID Numbers: AML 003
Study First Received: August 4, 2011
Last Updated: September 30, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University Health Network, Toronto:
chemotherapy
exercise
quality of life
cancer-related fatigue
elderly
physical fitness

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014