The Analysis of Fatigue on Tyrosine Kinase Inhibitor Therapy in Chronic Myeloid Leukaemia

Launched by IMPERIAL COLLEGE HEALTHCARE NHS TRUST · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how treatment with Tyrosine Kinase Inhibitors (TKIs) affects feelings of fatigue and sleep problems in patients with Chronic Myeloid Leukemia (CML). The researchers want to understand the differences between patients who experience fatigue and those who don’t, using special equipment to track sleep patterns and collecting blood samples to look for specific markers in the body.

To participate, individuals must be between 18 and 70 years old, have a confirmed diagnosis of CML, and have been on stable TKI therapy for at least six months. They should also have experienced fatigue for more than six months that affects their daily activities, or they should not have fatigue at all to be in the control group. Participants will wear a monitoring device for two weeks to track their activity and sleep, and they will keep a diary about their sleep. This trial is important as it may help improve understanding of how TKI therapy impacts quality of life for CML patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Informed consent
• • 2. Diagnosis of CML on treatment with tyrosine kinase inhibitor.
• • 3. On stable TKI therapy for at least 6 months duration
• • 4. Confirmation of ongoing chronic phase
• • 5. Male or females aged: 18 - 70 years old
• • 6. On-going fatigue for more than 6 months with impairment in daily life activities/ or no fatigue as described in point 7.
• • 7. If recruited to fatigue group then subjects would require both a - Chalder score \> or = 5 and a Modified Fatigue Impact scale score \> or = 43
• • 8. If recruited to control group, then subjects would require both a Chalder score \< or = 2 and a Modified Fatigue Impact Scale score \<33
• Exclusion Criteria:
• • 1. Not currently on treatment with a TKI inhibitor.
• • 2. Previous or active other neoplasm.
• • 3. Past medical history including diagnosed sleep disorder, depression and on current therapy, sleep apnoea, uncontrolled thyroid dysfunction and neurological disorder
• • 4. Active treatment with any of the following drug groups: anti cholinergic or anti muscarinic drugs, tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), Norepinephrine Dopamine Reuptake inhibitor (NDRI), Serotonin antagonist and reuptake inhibitor (SARI), Norepinephrine Antagonist serotonin antagonist (NASA), Monoamine oxidase inhibitors (MAO), regular sedating antihistamine use, regular opioid use, beta blockers, methyldopa, clonidine, benzodiazepines and zopiclone.
• • 5. Prior allogeneic SCT
• • 6. Have a history of alcohol or substance abuse