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

NCT04103359 | Terminated

• 2 other identifiers: 2019-07012019-A01877-50
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplatic Syndromes

Keywords

Myelodysplatic syndromes; elderly; fatigue; blood transfusion; physiopathology

Outcome Measures

Primary Outcomes (1)

• 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.

  10 days

Study Arms (1)

MDS patients

EXPERIMENTAL

MDS patients receiving blood transfusion

Other: Physiological tests to measure fatigue level

Interventions

Physiological tests to measure fatigue level OTHER

Physiological tests to measure fatigue level

MDS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Jean Monnet University: collaborator
• Institut de Cancérologie de la Loire: collaborator

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denis Guyotat, PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 25, 2019
• Study Start: October 20, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)