Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shabbir Alibhai, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01170598
First received: July 21, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

Fatigue, reduced quality of life and declines in physical function are common in patients undergoing chemotherapy for acute myeloid leukaemia (AML). Studies in other cancer patients undergoing treatment have shown that exercise improves these symptoms, but there are limited studies in AML. This study of a hospital-based exercise program will help determine if exercise is both feasible and helpful in improving symptoms among for AML patients undergoing chemotherapy.


Condition Intervention Phase
Acute Myeloid Leukemia
Other: Exercise
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Peak Aerobic Capacity (VO2peak) [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    The modified Bruce protocol is a walking-based treadmill test used to assess peak aerobic capacity. As the test progresses the intensity of each 3-minute work load increases. The test concludes when the participant reaches his maximal heart rate or volitional fatigue. The value attained on this test is measured in metabolic equivalents (METS). METS are a measure of exercise intensity and reflect the physical demands of an activity. In this context, a higher value achieved on the treadmill test (in METS) indicates work at a higher intensity and therefore a higher aerobic capacity.

  • 6-minute Walk Test [ Time Frame: Baseline, Post-induction (4-6 weeks) ] [ Designated as safety issue: No ]
    Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score.

  • Timed 10-chair Stands [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.

  • Grip Strength [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis.

  • Recruitment Rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation).

  • Retention [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Percentage of participants who remained in the study (did not withdraw voluntarily).

  • Program Adherence. [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate).


Secondary Outcome Measures:
  • Global Quality of Life [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL.

  • Fatigue [ Time Frame: Baseline, Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue.

  • Length of Stay [ Time Frame: Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Length of stay (date of admission to hospital to date of discharge).

  • Intensive Care Unit (ICU) Admission [ Time Frame: Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).

  • Development of Sepsis [ Time Frame: Post-induction (weeks 4-6) ] [ Designated as safety issue: No ]
    Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).


Enrollment: 35
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Other: Exercise
After obtaining daily medical clearance, patients will be approached 4-5 days per week to perform 30-45 minutes of supervised exercise with a Canadian Society for Exercise Physiology (CSEP) - Certified Exercise Physiologist. All exercise sessions will be as tolerated, based on patient symptoms.
Other Names:
  • Mixed-modality exercise
  • Resistance exercise training
  • Aerobic exercise training

Detailed Description:

Background: Acute myeloid leukaemia (AML) is a life-threatening haematological malignancy. Initial treatment with induction chemotherapy requires 4-5 weeks of hospitalization, with a risk of physical deconditioning, declines in quality of life (QOL), and significant fatigue. Four pilot exercise studies have demonstrated improved fitness, strength, QOL, and fatigue in patients undergoing induction, but are limited by small sample sizes, recruitment of mostly younger adults, inconsistent endpoints, and design issues. Prior to conducting a large multi-centre randomized controlled trial (RCT), important pilot work first needs to be done to demonstrate feasibility of a randomized trial of an exercise program in AML patients undergoing induction chemotherapy; to ensure safety; and to provide effect estimates of the intervention on fitness and QOL/fatigue endpoints.

Objectives: Primary objectives are: (1) to determine feasibility of recruitment and retention of adult AML patients to a randomized trial of supervised exercise and ability of patients to perform an exercise intervention in hospital; (2) to provide estimates of the effect of exercise on fitness parameters. Secondary objectives are: (1) to determine effects of exercise on QOL and fatigue; (2) to understand the impact of exercise on AML treatment tolerability; (3) to examine safety of the exercise intervention. Methods: Thirty-five patients age 18 or older with newly diagnosed or relapsed AML who are undergoing induction chemotherapy will be recruited at Princess Margaret Hospital. Participants will perform 30-45 minutes of supervised aerobic and resistance exercises 4-5 days per week. Primary outcomes are recruitment rate, exercise adherence rate, and impact on fitness measures (peak aerobic capacity (VO2peak), grip strength, leg strength, 6-minute walk test). QOL will be measured with the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). Fatigue will be measured using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). Treatment tolerability outcomes include length of stay, intensive care unit admission, and the development of sepsis. Outcomes over time will be assessed using mixed effects regression models.

Significance: Exercise is a promising intervention for improving fitness, QOL and treatment tolerability in AML patients undergoing induction chemotherapy. This pilot RCT will establish feasibility and safety, as well as provide efficacy estimates that will be vital to the design and conduct of a definitive multi-centre RCT of exercise in this patient population.

  Eligibility

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

Inclusion Criteria:

  • at least 18 years old
  • newly diagnosed AML, or relapsed AML after having been in complete remission for at least 6 months
  • initiating induction chemotherapy
  • ambulatory without need for human assistance
  • has consented to study
  • is medically cleared for participation by 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170598

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Toronto Rehabilitation Institute
Investigators
Principal Investigator: Shabbir MH Alibhai, MD, MSc University Health Network, Toronto Rehab Institute
  More Information

No publications provided by Toronto Rehabilitation Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shabbir Alibhai, Staff Physician and Scientist, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01170598     History of Changes
Other Study ID Numbers: AML002
Study First Received: July 21, 2010
Results First Received: February 8, 2012
Last Updated: April 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Toronto Rehabilitation Institute:
acute myeloid leukemia
AML
chemotherapy
exercise
quality of life
cancer-related fatigue
elderly
physical fitness
muscular strength
Feasibility
Efficacy
Safety

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

ClinicalTrials.gov processed this record on September 16, 2014