Acute Myeloid LeukemiaPhase 2NCT01170598

Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

A Phase 2 study testing Exercise in people with Acute Myeloid Leukemia, run by Toronto Rehabilitation Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Myeloid Leukemia
What is being tested?: Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteCanada
Study dates: Jun 2010to Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Princess Margaret Hospital
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase

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.

Read the 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.

Conditions: Acute Myeloid Leukemia
Being tested: Exercise
Keywords: acute myeloid leukemia, AML, chemotherapy, exercise, quality of life, cancer-related fatigue, elderly, physical fitness, muscular strength, Feasibility, Efficacy, Safety
Medical subject headings: Leukemia, Myeloid, Acute, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExerciseOther
Also called Mixed-modality exercise, Resistance exercise training, Aerobic exercise training
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.

Study groups in NCT01170598
Study group	Role	What they receive
Exercise	Experimental	Not described Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Aerobic Capacity (VO2peak)
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.
Measured: Baseline, Post-induction (weeks 4-6)
6-minute Walk Test
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.
Measured: Baseline, Post-induction (4-6 weeks)
Timed 10-chair Stands
Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.
Measured: Baseline, Post-induction (weeks 4-6)
Grip Strength
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.
Measured: Baseline, Post-induction (weeks 4-6)
Recruitment Rate
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).
Measured: Baseline
Retention
Percentage of participants who remained in the study (did not withdraw voluntarily).
Measured: Baseline, Post-induction (weeks 4-6)
Program Adherence.
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).
Measured: Baseline, Post-induction (weeks 4-6)

Secondary outcomes (5)

Global Quality of Life
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.
Measured: Baseline, Post-induction (weeks 4-6)
Fatigue
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.
Measured: Baseline, Post-induction (weeks 4-6)
Length of Stay
Length of stay (date of admission to hospital to date of discharge).
Measured: Post-induction (weeks 4-6)
Intensive Care Unit (ICU) Admission
Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).
Measured: Post-induction (weeks 4-6)
Development of Sepsis
Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).
Measured: Post-induction (weeks 4-6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Mar 2011

First posted27 Jul 2010 (estimated)
Study startJun 2010
Primary completionFeb 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01170598
Sponsor's protocol ID: AML002
Status last verified: Apr 2012
First submitted: 21 Jul 2010
Last updated: 20 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Alibhai SM, O'Neill S, Fisher-Schlombs K, Breunis H, Brandwein JM, Timilshina N, Tomlinson GA, Klepin HD, Culos-Reed SN. A clinical trial of supervised exercise for adult inpatients with acute myeloid leukemia (AML) undergoing induction chemotherapy. Leuk Res. 2012 Oct;36(10):1255-61. doi: 10.1016/j.leukres.2012.05.016. Epub 2012 Jun 21.
PubMed 22726923

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase
ClinicalTrials.gov ID: NCT01170598
Acronym / sponsor ID: AML002
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia, AML, chemotherapy, exercise, quality of life, cancer-related fatigue, elderly, physical fitness
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Toronto Rehabilitation InstituteUniversity, hospital or other
Study start: Jun 2010
Primary completion: Feb 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 27 Jul 2010 (estimated)
Results: Posted 13 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Exercise	Experimental	Other: Exercise

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

has another active malignancy
has life expectancy < 1 month, physician determined
has significant comorbidity
has uncontrolled pain
has haemodynamic instability

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExerciseAlso: Mixed-modality exercise, Resistance exercise training, Aerobic exercise trainingAfter 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	Exercise

Primary outcome

Peak Aerobic Capacity (VO2peak)
Time frame: Baseline, Post-induction (weeks 4-6)
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)
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)
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)
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
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)
Percentage of participants who remained in the study (did not withdraw voluntarily).
Program Adherence.
Time frame: Baseline, Post-induction (weeks 4-6)
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).

5 secondary outcomes

Global Quality of Life
Time frame: Baseline, Post-induction (weeks 4-6)
Fatigue
Time frame: Baseline, Post-induction (weeks 4-6)
Length of Stay
Time frame: Post-induction (weeks 4-6)
Intensive Care Unit (ICU) Admission
Time frame: Post-induction (weeks 4-6)
Development of Sepsis
Time frame: Post-induction (weeks 4-6)

Results and safety

Results posted to the registry on 13 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise	35	29

Primary outcome: Peak Aerobic Capacity (VO2peak)

Time frame: Baseline, Post-induction (weeks 4-6). Mean (Standard Deviation). Unit: metabolic equivalent (METS)

Measure	Exercise n = 35
Baseline	6.9 (1.8)
Post-induction (weeks 4-6)	7.4 (1.7)

Primary outcome: 6-minute Walk Test

Time frame: Baseline, Post-induction (4-6 weeks). Mean (Standard Deviation). Unit: feet

Measure	Exercise n = 35
Baseline	962.5 (286.3)
Post-induction (weeks 4-6)	1176.2 (360.6)

Primary outcome: Timed 10-chair Stands

Time frame: Baseline, Post-induction (weeks 4-6). Mean (Standard Deviation). Unit: seconds

Measure	Exercise n = 35
Baseline	33.0 (26.0)
Post-induction (weeks 4-6)	31.1 (11.2)

Primary outcome: Grip Strength

Time frame: Baseline, Post-induction (weeks 4-6). Mean (Standard Deviation). Unit: kilograms

Measure	Exercise n = 35
Baseline	23.9 (11.0)
Post-induction (weeks 4-6)	21.6 (11.0)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were captured over the course of the intervention (9 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise	0 of 35 (0%)	1 of 35 (2.9%)	Not reported

Limitations and caveats (from the sponsor): Although as per study design, limitations include the lack of a control group due to non-randomization, a small sample size and lack of generalizability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22726923Alibhai SM, O'Neill S, Fisher-Schlombs K, Breunis H, Brandwein JM, Timilshina N, Tomlinson GA, Klepin HD, Culos-Reed SN. A clinical trial of supervised exercise for adult inpatients with acute myeloid leukemia (AML) undergoing induction chemotherapy. Leuk Res. 2012 Oct;36(10):1255-61. doi: 10.1016/j.leukres.2012.05.016. Epub 2012 Jun 21.

Related trials for Acute Myeloid Leukemia

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shabbir MH Alibhai, MD, MSc principal investigator

University Health Network, Toronto Rehab Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exercise in people with Acute Myeloid Leukemia, run by Toronto Rehabilitation Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Aerobic Capacity (VO2peak) (time frame: Baseline, Post-induction (weeks 4-6)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01170598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.