An Exercise Trial for Acute Myeloid Leukaemia (AML) Patients Undergoing Induction Chemotherapy

NCT01446081 | Completed Phase 2

• 1 other identifier: AML 003
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

chemotherapy; exercise; quality of life; cancer-related fatigue; elderly; physical fitness

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Treatment tolerability

  Post-induction (weeks 4-6), Post-consolidation (weeks 10-12)

Study Arms (2)

Exercise

EXPERIMENTAL

Patients will receive an individualized, supervised mixed-modality exercise program created by a CSEP-Certified Exercise Physiologist (CEP).

Behavioral: Exercise

Control

NO INTERVENTION

Participants assigned to this arm will receive usual care.

Interventions

Exercise BEHAVIORAL

Patients will receive an individualized, supervised mixed-modality exercise program created by a CSEP-Certified Exercise Physiologist (CEP). They will perform 30 minutes of light to moderate intensity exercise 4-5 times/week tailored to ability. Aerobic exercise will primarily consist of walking and/or stationary cycling. Resistance exercises will target large muscle groups using dumbbells, resistance bands, and stability balls. The CEP will monitor and document details of each exercise session as well as patient tolerance and symptoms, and make appropriate adaptations to ensure program safety and progression. Exercise intensity and duration will vary based on patient tolerance, symptoms and blood parameters. Exercise equipment will be carefully sanitized between each use.

Exercise

Eligibility Criteria

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

You may qualify if:

• 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

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

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Motor Activity

Interventions

Exercise

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

Study Officials

• Shabbir Alibhai, MD, MSc

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: October 4, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

CA (1)