Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

NCT01170598 | Completed Phase 2 Results

• 1 other identifier: AML002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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

• Retention

  Percentage of participants who remained in the study (did not withdraw voluntarily).

  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).

  Baseline, Post-induction (weeks 4-6)

Secondary Outcomes (5)

• Global Quality of Life

  Baseline, Post-induction (weeks 4-6)

• Fatigue

  Baseline, Post-induction (weeks 4-6)

• Length of Stay

  Post-induction (weeks 4-6)

• Intensive Care Unit (ICU) Admission

  Post-induction (weeks 4-6)

• Development of Sepsis

  Post-induction (weeks 4-6)

Study Arms (1)

Exercise

EXPERIMENTAL

Other: Exercise

Interventions

Exercise OTHER

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.

Also known as: Mixed-modality exercise, Resistance exercise training, Aerobic exercise training

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 22726923 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Limitations and Caveats

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.

Results Point of Contact

• Title: Sara O'Neill
• Organization: University Health Network

o'neill.sara@torontorehab.on.ca

416-597-3422

Study Officials

• Shabbir MH Alibhai, MD, MSc

  University Health Network, Toronto Rehab Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician and Scientist

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 27, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 20, 2012
• Results First Posted: April 13, 2012

Record last verified: 2012-04

Locations

CA (1)