Search / Trial NCT06233890

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

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

Trial Information

Current as of December 22, 2024

Active, not recruiting

Keywords

Tyrosine Kinase Inhibitor Chronic Myeloid Leukaemia Sleep Disturbance Fatigue Activin B L Carnitine

ClinConnect Summary

The therapeutic landscape of CML has evolved significantly, as a result of targeted 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 prevalenc...

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

Trial Officials

Dragana Milojkovic, MbChB, PHD

Principal Investigator

Imperial NHS Healthcare Trust

About Imperial College Healthcare Nhs Trust

Imperial College Healthcare NHS Trust is a leading healthcare provider in London, renowned for its commitment to delivering high-quality patient care and advancing medical research. As an integral part of the NHS, the Trust encompasses a range of specialized services and facilities, including multiple hospitals and outpatient centers, where it fosters a collaborative environment for clinical trials. With a focus on innovation and excellence, Imperial College Healthcare NHS Trust supports a diverse portfolio of clinical research initiatives aimed at translating scientific discoveries into effective treatments and improving health outcomes for patients. Its partnership with Imperial College London enhances its capabilities in cutting-edge research, making it a pivotal institution in the landscape of healthcare and clinical trials.

Locations

London, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0