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

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Myelodysplatic Syndromes

Treatments

Other: Physiological tests to measure fatigue level

Study type

Interventional

Funder types

Other

Identifiers

NCT04103359

2019-A01877-50 (Other Identifier)

2019-0701

Details and patient eligibility

About

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.

Full description

One hypothesis is that patients who exhibited persistent fatigue following a blood- transfusion- 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.