Myelodysplatic SyndromesFITMENCT04103359
Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy
A study testing Physiological tests to measure fatigue level in people with Myelodysplatic Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplatic Syndromes
- What is being tested?
- Physiological tests to measure fatigue level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2020to 20 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)
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.
Read the 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.
- Conditions
- Myelodysplatic Syndromes
- Being tested
- Physiological tests to measure fatigue level
- Keywords
- Myelodysplatic syndromes, elderly, fatigue, blood transfusion, physiopathology
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological tests to measure fatigue levelOther
Physiological tests to measure fatigue level
| Study group | Role | What they receive |
|---|---|---|
| MDS patients | Experimental | MDS patients receiving blood transfusion Receives: Other: Physiological tests to measure fatigue level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Fatigue using FACIT-F questionnaire
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start20 Oct 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Why it stopped: inclusion rate too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplatic SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jean Monnet University, Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Denis Guyotat, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103359
- Sponsor's protocol ID
- 2019-0701
- Other IDs
- 2019-A01877-50
- Acronym
- FITME
- Status last verified
- May 2023
- First submitted
- 24 Sep 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)
- ClinicalTrials.gov ID
- NCT04103359
- Acronym / sponsor ID
- FITME / 2019-0701
- Conditions
- Myelodysplatic Syndromes
- Keywords
- Myelodysplatic syndromes, elderly, fatigue, blood transfusion, physiopathology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion rate too low
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Jean Monnet University, Institut de Cancérologie de la Loire
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDS patients | Experimental | Other: Physiological tests to measure fatigue levelMDS patients receiving blood transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological tests to measure fatigue levelPhysiological tests to measure fatigue level | Other | MDS patients |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: inclusion rate too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
Related trials for Myelodysplatic Syndromes
RecruitingObservational study
Caris Chromoseq Data Collection
Acute Myeloid Leukemia (AML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Guyotat, PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological tests to measure fatigue level in people with Myelodysplatic Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inclusion rate too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Fatigue using FACIT-F questionnaire (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.