Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Measurement of Fatigue using FACIT-F questionnaire
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Measurement of Fatigue using FACIT-F questionnaire
Time Frame: 10 days
Measurement of Fatigue will be performed using FACIT-F questionnaire. This is a questionnaire with 13 questions about which the patient is positioned on a Likert scale ranging from 1 to 5 (1 = quite, 5 = not at all). By adding the answers, a score out of 65 is obtained. Unlike other scales the higher the score the less the patient is tired. As an indication, the non-sick average positions is 40.1 on this scale.
Secondary Outcomes
No secondary outcomes reported