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CML and muscle function


- candidate number27078
- NTR NumberNTR6373
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-apr-2017
- Secondary IDs2016-3015 NL59390.091.16
- Public TitleCML and muscle function
- Scientific TitleThe relation between muscle function and muscle pain in patients with chronic myeloid leukemia (CML): a pilot study
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedChronic Myeloid Leukemia (CML)
- Inclusion criteria- Age: > 18 years old
- CML ĖCP patient using TKI
- Able to give informed consent
- Exclusion criteria- Known hereditary muscle defect
- Medication known to cause muscle pain (statins)
- Evident prolonged QTc interval (>500 msec)
- Contra-indication for the maximal aerobic exercise test
Contra-indications for a muscle biopsy (i.e. use of anticoagulants or/and allergic reaction to lidocaÔne)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2017
- planned closingdate1-jun-2018
- Target number of participants30
- InterventionsNone
- Primary outcome- muscle function
- Muscle energy metabolism
- Aerobic capacity
- Secondary outcomeNone
- TimepointsCross-sectional
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Lando Janssen
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryChronic myeloid leukemia (CML) became a disease with a good prognosis since the application of the targeted tyrosine kinase inhibitors (TKI) therapy since 2000. However, musculoskeletal pain/myalgia is a frequently reported adverse drug reaction of TKIs (80% of patients reporting an adverse drug reaction, report muscle complaints), contributing to poor drug adherence. Little research has been done on the pathogenesis and clinical management of musculoskeletal problems during TKI therapy. This is of outmost importance since: i) the onset of musculoskeletal problems contributes to the poor adherence to TKI therapy and ii) continuous, potentially lifelong treatment with TKIs is required for CML chronic phase (CP) disease control which impacts quality of life. Therefore, this study will investigate whether differences exist in muscle function, muscle energy metabolism and cardiorespiratory fitness in CML CP patients using TKIís with muscle complaints, compared to CML CP patients using TKIís without muscle complaints, and controls.
- Main changes (audit trail)
- RECORD12-apr-2017 - 19-jun-2017


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