FITME: Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MDS patients MDS patients receiving blood transfusion |
Other: Physiological tests to measure fatigue level
Physiological tests to measure fatigue level
|
Outcome Measures
Primary Outcome Measures
- Measurement of Fatigue using FACIT-F questionnaire [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient affiliated to a social security regimen or beneficiary of the same
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Signed written informed consent form
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Patient, ≥ 18 years-old, with established diagnosis of myelodysplastic syndrome with low or intermediate-1 risk cytogenetic profile
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FACIT-F score ≤ 34,
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Indication of blood transfusion.
Exclusion Criteria:
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Contra-indication to experimental procedures and/or physical exercise,
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Concomitant cancer diagnosis,
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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
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Refusing participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Saint-Etienne | Saint-Étienne | France | 42055 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
- Laboratoire Interuniversitaire de Biologie de la Motricité - Jean Monnet University Saint-Etienne
- Institut de Cancérologie de la Loire
Investigators
- Principal Investigator: Denis Guyotat, PhD, CHU de Saint-Etienne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-0701
- 2019-A01877-50