Gazi University Faculty of Health Science Department of PhysioTherapy
Ankara, 06010, Turkey (Türkiye)
NCT Number: NCT03448471
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.
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Notify Me18 year–65 year
All sexes
Observational
Ankara, 06010, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: First day
Evaluated with a hand-held dynamometer
Time frame: First day
Evaluated for specifing to functional exercise capacity
Time frame: First day
Evaluated with a mouth pressure device
Time frame: First day
Evaluated with a spirometer
Time frame: First day
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 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
Used for measurement of depression levels
Time frame: First day
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.
Gazi University
Other
Pulmonary and Extra-pulmonary Characteristics in Severe-fatigued Allogeneic Hematopoietic Stem Cell Transplantation Recipients
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