Clinical trial NCT01170598: Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy
Official title: A Pilot Exercise RCT for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy: Pre-randomization Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
AML
chemotherapy
exercise
quality of life
cancer-related fatigue
elderly
physical fitness
muscular strength
Feasibility
Efficacy
Safety
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Peak Aerobic Capacity (VO2peak)
timeFrame: Baseline, Post-induction (weeks 4-6)
measure: 6-minute Walk Test
timeFrame: Baseline, Post-induction (4-6 weeks)
measure: Timed 10-chair Stands
timeFrame: Baseline, Post-induction (weeks 4-6)
measure: Grip Strength
timeFrame: Baseline, Post-induction (weeks 4-6)
measure: Recruitment Rate
timeFrame: Baseline
measure: Retention
timeFrame: Baseline, Post-induction (weeks 4-6)
measure: Program Adherence.
timeFrame: Baseline, Post-induction (weeks 4-6)
Secondary outcomes:
measure: Global Quality of Life
timeFrame: Baseline, Post-induction (weeks 4-6)
measure: Fatigue
timeFrame: Baseline, Post-induction (weeks 4-6)
measure: Length of Stay
timeFrame: Post-induction (weeks 4-6)
measure: Intensive Care Unit (ICU) Admission
timeFrame: Post-induction (weeks 4-6)
measure: Development of Sepsis
timeFrame: Post-induction (weeks 4-6)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto Rehab Institute
name: Shabbir MH Alibhai, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.