An observational study in Stem Cell Transplantation and Fatigue, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Gazi University · Observational
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Among 18 studies in Fatigue by Gazi University — 1 open to participants now, 1 under way, none of them phase 3. Fatigue · Gazi University.
Among the 18 studies in Fatigue by Gazi University, this one is the 6th largest by enrollment of the 10 observational ones that give a count, is the only one that started in 2012, is one of 10 observational ones, and was the 4th registered.
2,231 studies on the registry are indexed under Fatigue; 427 are open to participants now.
Browse Fatigue studies →1 of the 18 studies in Fatigue by Gazi University is open now, in 1 country. Recruiting first, the newest first:
Gazi University · Sites in Turkey
Ages 18–65
By country, each count listing its studies:
Of the 239 Fatigue studies recruiting now, 111 (46%) set no upper age limit and 98 (41%) stop at 75 or younger; 23 take children under 18; 73 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2012.
This study's enrollment of 49 is below the median of 99 across 406 observational studies indexed under Fatigue.
Median enrollment 30 across the 8 interventional studies, 60 across the 10 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
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Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Fatigue by Gazi University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Fatigue is the most complained side effect that may last for months or even years after treatment ends in patients with cancer. Cancer-related fatigue is described as 'a distressing, persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning'. The cancer-related fatigue observed in 80% of cancer patients received chemotherapy and/or radiotherapy, yet underlying mechanism of cancer-related fatigue is not still clearly explained.
Hematological malignancy itself and its treatments including chemotherapy, radiotherapy, surgery, medical treatment and/or allogeneic or autologous hematopoietic stem cell transplantation cause lots of early and late adverse effects such as appetite loss, nausea and vomiting, diarrhea, fatigue, sleep disturbance, pain, cardiopulmonary and neuromuscular deconditioning, impairments in mobility, muscle weakness and increased risk of fall.
Hematopoietic stem cells collected from bone marrow, peripheral blood or umbilical cord blood of healthy donors are infused into allogeneic hematopoietic stem cell transplantation (allogeneic-HSCT) recipients with hematological malignancy. Allogeneic-HSCT is highly associated with transplant-related mortality, morbidity, graft-versus host disease and another various complications. Because of the above-mentioned risks, recipients and their caregivers are required to remain close to transplant center in the acute phase of transplantation, approximately 100 days. As a consequence, hematopoietic stem cell transplantation has a negative impact on quality of life in recipients and their caregivers who report fatigue, sleep and sexual problems and emotional distress. Especially fatigue is a destructive symptom for recipients, exists before hematopoietic stem cell transplantation and further deteriorates during the first three weeks after hematopoietic stem cell transplantation. Moreover baseline fatigue severity continues until one year after hematopoietic stem cell transplantation.
Although fatigue has been one of the most intensely experienced symptoms by allogeneic-HSCT recipients, no study has compared pulmonary functions, albumin-hemoglobin-white blood cell levels, dyspnea, respiratory and peripheral muscle strength, submaximal exercise capacity, depression and quality of life between severe-fatigued and non-severe-fatigued allogeneic-HSCT recipients, yet. Therefore investigators aimed to compare the effects of severe fatigue on aforementioned outcomes in recipients.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Peripheral muscle strength
Evaluated with a hand-held dynamometer
Time frame: First day
6-minute walking test
Evaluated for specifing to functional exercise capacity
Time frame: First day
Respiratory muscle strength
Evaluated with a mouth pressure device
Time frame: First day
Pulmonary function test
Evaluated with a spirometer
Time frame: First day
Fatigue Severity Scale
Fatigue severity was measured using Turkish version of Fatigue Severity Scale. Self-administered questionnaire is consisting of nine questions. An average score is determined on a seven-point scale. Patients mark a number from 1 to 7 for each 9 question which indicates from strong disagreement to strong agreement, respectively. The scale is used in cancer patients.
Time frame: First day
Modified Medical Research Council Dyspnea scale (MMRC)
Modified Medical Research Council Dyspnea scale was used to evaluate severity of dyspnea during daily living activities. Dyspnea is graded from zero (absence of dyspnea during strenuous exercise) to four (presence of dyspnea during all daily living activities).
Time frame: First day
Beck Depression Inventory-II (Turkish version)
Used for measurement of depression levels
Time frame: First day
European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
Quality of life was measured using Turkish version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 (EORTCQLQ) which is widely used as health related quality of life questionnaire in cancer patients. The cancer-specific questionnaire has 30 questions and incorporates five functional scales, three symptom scales, a global health status and several single items. All item scores are transformed to 0-100. Higher values indicate higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased symptoms in symptom scales.
Time frame: First day
Plan to share: No — 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.
The record gives a start of Mar 2012, a primary completion of Aug 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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