Acute Myeloid Leukemia Clinical Trial
Official title:
A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase
Verified date | April 2012 |
Source | Toronto Rehabilitation Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | March 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Toronto Rehabilitation Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, Post-induction (weeks 4-6) | No |
Primary | 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. | Baseline, Post-induction (4-6 weeks) | No |
Primary | Timed 10-chair Stands | Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible. | Baseline, Post-induction (weeks 4-6) | No |
Primary | 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. | Baseline, Post-induction (weeks 4-6) | No |
Primary | 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). | Baseline | No |
Primary | Retention | Percentage of participants who remained in the study (did not withdraw voluntarily). | Baseline, Post-induction (weeks 4-6) | No |
Primary | 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). | Baseline, Post-induction (weeks 4-6) | No |
Secondary | 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. | Baseline, Post-induction (weeks 4-6) | No |
Secondary | 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. | Baseline, Post-induction (weeks 4-6) | No |
Secondary | Length of Stay | Length of stay (date of admission to hospital to date of discharge). | Post-induction (weeks 4-6) | No |
Secondary | Intensive Care Unit (ICU) Admission | Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course). | Post-induction (weeks 4-6) | No |
Secondary | Development of Sepsis | Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course). | Post-induction (weeks 4-6) | No |
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