Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy
NCT number | NCT01446081 |
Other study ID # | AML 003 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2011 |
Est. completion date | May 2013 |
Verified date | November 2019 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | May 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in quality of life at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) (QOL) | EORTC QLQ-C30 (questionnaire) | Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12) | |
Primary | Change from baseline in fatigue at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) | FACT-F (questionnaire) | Baseline (within 5 days of starting chemo), Post-induction (weeks 4-6), Post-consolidation (weeks 10-12) | |
Primary | Change from baseline in fitness measures at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) | 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 | Treatment tolerability | 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) |
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