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

Titre officiel

A Phase II Exercise RCT for AML Patients Undergoing Induction Chemotherapy

Sommaire:

La diminution de la qualité de vie, la fatigue et la perte de fonctions physiques sont courantes chez les patients qui reçoivent une chimiothérapie contre la leucémie aiguë myéloïde (LAM). Les chercheurs ont terminé une étude pilote ayant révélé que l’exercice pendant une chimiothérapie active contre la LAM est une pratique réalisable et sans danger et qu’elle peut atténuer les symptômes et améliorer les fonctions physiques. Les chercheurs proposent maintenant de comparer notre programme d’exercices supervisés à l’hôpital aux soins habituels pour savoir si l’exercice peut atténuer les symptômes, améliorer les fonctions physique et accroître la tolérabilité au traitement.

Description de l'essai

Primary Outcome:

• Change from baseline in quality of life at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1) (QOL)
• Change from baseline in fatigue at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)
• Change from baseline in fitness measures at weeks 4-6 (post-induction) and weeks 10-12 (post-consolidation 1)

Secondary Outcome:

• Treatment tolerability

Acute myeloid leukaemia (AML) is a life-threatening malignant blood disorder. Curative treatment requires multiple cycles of intensive chemotherapy. The first cycle, induction, is the most intense and intended to achieve complete disease remission (CR). Induction therapy requires 4-6 weeks of inpatient admission and is associated with extended bed rest and multiple toxicities, leading to physical deconditioning. Regular exercise during induction may reduce declines in physical fitness, leading to improved quality of life (QOL), reduced fatigue, improved tolerance of chemotherapy, and potentially greater survival. Four prior studies of exercise in AML patients undergoing induction have suggested improvements in QOL, fatigue, physical function, and treatment tolerability. However, all 4 studies suffered from major limitations including small sample sizes, design limitations, generalizability concerns, and limited safety information. The investigators conducted a pilot non-randomized study in 35 AML patients and demonstrated feasibility, safety, and potential improvements in QOL, fatigue, and physical fitness outcomes. The investigators now propose a rigorous evaluation of the intervention in a phase II randomized controlled trial (RCT). Primary objectives include: (1) To determine the efficacy of a supervised mixed-modality exercise program during induction chemotherapy on QOL and fatigue; (2) To determine the efficacy on physical fitness. Our secondary objective is to determine the efficacy on AML treatment tolerability (hospital length of stay, development of sepsis, intensive care unit (ICU) admission, delays in consolidation chemotherapy).

Voir cet essai sur ClinicalTrials.gov