Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy (FITME)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2022
  • participants needed
    26
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 22 March 2022

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 IdentifierNCT04103359
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient affiliated to a social security regimen or beneficiary of the same
Signed written informed consent form
Patient, ≥ 18 years-old, with established diagnosis of myelodysplastic syndrome with low or intermediate-1 risk cytogenetic profile
FACIT-F score ≤ 34
Indication of blood transfusion

Exclusion Criteria

Contra-indication to experimental procedures and/or physical exercise
Concomitant cancer diagnosis
Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
Refusing participation
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