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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04103359
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Laboratoire Interuniversitaire de Biologie de la Motricité - Jean Monnet University Saint-Etienne
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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
Myelodysplatic Syndromes Other: Physiological tests to measure fatigue level Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MDS patients
MDS patients receiving blood transfusion
Other: Physiological tests to measure fatigue level
Physiological tests to measure fatigue level

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04103359

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Contact: Denis Guyotat, PhD, MD 0477917000 ext +33
Contact: Elisabeth Daguenet, PhD 0477917089 ext +33

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Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42270
Contact: Denis Guyotat, PhD, MD         
Contact: Elisabeth Daguenet, PhD         
Principal Investigator: Denis Guyotat, PhD, MD         
Sub-Investigator: Christelle Portois, MD         
Sub-Investigator: Emilie Chalayer, MD         
Sub-Investigator: Karine Augeul-Meunier, MD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Laboratoire Interuniversitaire de Biologie de la Motricité - Jean Monnet University Saint-Etienne
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Principal Investigator: Denis Guyotat, PhD Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire Identifier: NCT04103359    
Other Study ID Numbers: 2019-0701
2019-A01877-50 ( Other Identifier: ANSM )
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de la Loire:
Myelodysplatic syndromes
blood transfusion
Additional relevant MeSH terms:
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Signs and Symptoms