Clinical trial NCT04103359: Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy
Official title: Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myelodysplatic Syndromes
Keywords: Myelodysplatic syndromes
elderly
fatigue
blood transfusion
physiopathology
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Jean Monnet University
name: Institut de Cancérologie de la Loire
First posted: 2019-09-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of Fatigue using FACIT-F questionnaire
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Denis Guyotat, PhD
role: PRINCIPAL_INVESTIGATOR
References: