Tire Study: Analysis of Fatigue on Chronic Myeloid Leukaemia Therapy
Research type
Research Study
Full title
Tire Study: Analysis of Fatigue on Chronic Myeloid Leukaemia Therapy
IRAS ID
198897
Contact name
Dragana Milojkovic
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
2 years, 2 months, 29 days
Research summary
The landscape of Chronic Myeloid Leukaemia (CML) has evolved significantly, as a result of targeted tyrosine kinase inhibitors (TKI) therapy, over the past 2 decades, with patients now experiencing a near normal life expectancy due to achievement of deep molecular responses. As a consequence, the appropriate management of drug related adverse events to ensure minimal impact on quality of life has never been more vital. Fatigue and sleep disturbance are commonly described and whilst it is evident that there is a strong correlation between fatigue and TKI therapy the mechanism which drives this remains unknown. In general, the prevalence of TKI induced fatigue (TKI-FS) and predicting factors is largely unexplored. This study will evaluate fatigue and sleep disturbance in CML patients on TKI therapy. It is an observational study which aims to determine alterations of sleep patterns and how this correlates with fatigue in this cohort of patients, using blood parameters, rest-activity monitoring via motion watch monitoring and serum biomarkers. The study will recruit eligible CML patients who have experienced significant fatigue with an impact on their quality of life (Group A) and healthy controls who are also CML patients on TKI therapy with no symptoms of fatigue, as ascertained by validated questionnaires (Group B).
REC name
West of Scotland REC 3
REC reference
22/WS/0160
Date of REC Opinion
21 Dec 2022
REC opinion
Further Information Favourable Opinion