NCT03448471|Completed
Severe Fatigue in Stem Cell Transplantation
Pulmonary and Extra-pulmonary Characteristics in Severe-fatigued Allogeneic Hematopoietic Stem Cell Transplantation Recipients
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Pulmonary and Extra-pulmonary Characteristics in Severe-fatigued Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Sponsor study identifier
observational
49
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Fatigue is a common symptom during allogeneic-hematopoietic stem cell transplantation (allo-HSCT). However, effects of severe fatigue on pulmonary functions, blood cells, dyspnea, muscle strength, exercise capacity, depression and quality of life (QOL) in allo-HSCT recipients are still unknown.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2017
Actual (reported)December 2017
Actual (reported)February 22, 2018
Actual (reported)February 28, 2018
Actual (reported)Peripheral muscle strength
Evaluated with a hand-held dynamometer
First day
6-minute walking test
First day
Respiratory muscle strength
First day
Pulmonary function test
First day
Fatigue Severity Scale
First day
Modified Medical Research Council Dyspnea scale (MMRC)
First day
These recipients had Fatigue Severity Scale score ≥36. All recipients evaluated with similar methods. Meaurements were Pulmonary function tests, Respiratory muscle strength, Peripheral muscle strength, Functional exercise capacity, Dyspnea, Fatigue, Depression and Quality of life.
These recipients had Fatigue Severity Scale score \<36. All recipients evaluated with similar methods. Meaurements were Pulmonary function tests, Respiratory muscle strength, Peripheral muscle strength, Functional exercise capacity, Dyspnea, Fatigue, Depression and Quality of life.
Forty-nine allogeneic-HSCT recipients who were at minimum 100 days status post-transplantation, between ages of 18 and 65, under standard medical treatment, transplanted at Bone Marrow Transplantation Unit of University Faculty of Medicine were included. Twenty four severe-fatigued (Fatigue Severity Scale score ≥36) and 25 non-severe-fatigued recipients were compared.Study was approved by local Ethics Committee and informed consent was obtained from all individual participants included in study.
Gazi University Faculty of Health Science Department of PhysioTherapy
Ankara, 06010, Turkey (Türkiye)
Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.
Soutar RL, King DJ. Bone marrow transplantation. BMJ. 1995 Jan 7;310(6971):31-6. doi: 10.1136/bmj.310.6971.31. No abstract available.
Papadopoulos EB, Jakubowski AA. Novel approaches in allogeneic stem cell transplantation. Curr Oncol Rep. 2006 Sep;8(5):325-36. doi: 10.1007/s11912-006-0054-0.
Gülşah Barğı, PhD.
Gazi University
Meral Boşnak Güçlü, PhD.
Gazi University
Gülsan Türköz Sucak, PhD.
Bahçeşehir University
49 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Fatigue Before and After Exercise in Patients With Advanced Cancer Stage
Contact the study team to confirm eligibility.
Wulff-Burchfield EM, Jagasia M, Savani BN. Long-term follow-up of informal caregivers after allo-SCT: a systematic review. Bone Marrow Transplant. 2013 Apr;48(4):469-73. doi: 10.1038/bmt.2012.123. Epub 2012 Jun 25.
Polomeni A, Lapusan S, Bompoint C, Rubio MT, Mohty M. The impact of allogeneic-hematopoietic stem cell transplantation on patients' and close relatives' quality of life and relationships. Eur J Oncol Nurs. 2016 Apr;21:248-56. doi: 10.1016/j.ejon.2015.10.011. Epub 2015 Nov 18.
Frodin U, Lotfi K, Fomichov V, Juliusson G, Borjeson S. Frequent and long-term follow-up of health-related quality of life following allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2015 Nov;24(6):898-910. doi: 10.1111/ecc.12350. Epub 2015 Jul 7.
Primary Completion
August 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
March 12, 2018
Record last verified: 2018-03
There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.
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Source: ClinicalTrials.gov.
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