Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT04103359
Status:
TERMINATED
Last Update Posted:
2023-05-06
First Post:
2019-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'inclusion rate too low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-24', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Fatigue using FACIT-F questionnaire', 'timeFrame': '10 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplatic syndromes', 'elderly', 'fatigue', 'blood transfusion', 'physiopathology'], 'conditions': ['Myelodysplatic Syndromes']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient affiliated to a social security regimen or beneficiary of the same\n* Signed written informed consent form\n* Patient, ≥ 18 years-old, with established diagnosis of myelodysplastic syndrome with low or intermediate-1 risk cytogenetic profile\n* FACIT-F score ≤ 34,\n* Indication of blood transfusion.\n\nExclusion Criteria:\n\n* Contra-indication to experimental procedures and/or physical exercise,\n* Concomitant cancer diagnosis,\n* 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\n* Refusing participation."}, 'identificationModule': {'nctId': 'NCT04103359', 'acronym': 'FITME', 'briefTitle': 'Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)', 'orgStudyIdInfo': {'id': '2019-0701'}, 'secondaryIdInfos': [{'id': '2019-A01877-50', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDS patients', 'description': 'MDS patients receiving blood transfusion', 'interventionNames': ['Other: Physiological tests to measure fatigue level']}], 'interventions': [{'name': 'Physiological tests to measure fatigue level', 'type': 'OTHER', 'description': 'Physiological tests to measure fatigue level', 'armGroupLabels': ['MDS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Denis Guyotat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jean Monnet University', 'class': 'OTHER'}, {'name': 'Institut de Cancérologie de la Loire', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}