Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy (FITME)
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- STATUS
- Recruiting
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- End date
- Nov 30, 2022
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- participants needed
- 26
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- sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Summary
At present, it is unclear why some myelodysplastic patients (MDS) receiving blood transfusion therapy exhibit an increase in Hemoglobin (Hb) without a concurrent improvement in fatigue. Research is thus required to elucidate on why fatigue persists in some MDS patients in order to devise strategies to alleviate fatigue in "non-responders" to blood transfusion.
Description
One hypothesis is that patients who exhibited persistent fatigue following a bloodtransfusion - induced increase in Hb have an impaired ability to utilize oxygen at the peripheral level. This could be the consequence of impairments in vascular function, mediated by endothelial dysfunction as a result of transfusion-induced iron-overload and oxidative stress associated with the disease. Taking the current gaps in knowledge pertaining to MDS-related fatigue into account, the objective of this study is to improve understanding on the aetiology fatigue in MDS patients. To achieve this aim, the study will measure a comprehensive group of patient-reported and disease-related outcomes: i) prior to blood transfusion therapy when Hb levels are low and; ii) following blood transfusion therapy, when Hb levels have been increased. Results from the post-transfusion tests will be analyzed to determine which participants remain fatigued despite an increase in Hb, and which participants shown an improvement in fatigue.
Details
| Condition | Myelodysplatic Syndromes |
|---|---|
| Treatment | Physiological tests to measure fatigue level |
| Clinical Study Identifier | NCT04103359 |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Last Modified on | 22 March 2022 |
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