ID
Bron
Aandoening
Chronic myeloid leukemia, CML, chronische myeloïde leukemie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- muscle function <br>
- Muscle energy metabolism <br>
- Aerobic capacity
Achtergrond van het onderzoek
Chronic 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 TKI’s with muscle complaints, compared to CML CP patients using TKI’s without muscle complaints, and controls.
Onderzoeksopzet
Cross-sectional
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age: > 18 years old
- CML –CP patient using TKI
- Able to give informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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 lidocaïne)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6209 |
NTR-old | NTR6373 |
Ander register | NL59390.091.16 : 2016-3015 |