Severe Fatigue in Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pulmonary and Extra-pulmonary Characteristics in Severe-fatigued Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Conditions
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Fatigue, Stem Cell Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being an hematopoietic stem cell transplantation recipient during the intermediate/late post-transplant phase (>100 days), 18-65 years of age under standard medications. Exclusion Criteria: having a cognitive disorder, orthopedic or neurological disease with a potential to affect functional capacity, comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia, problems which may prevent training such as visual problems and mucositis having metastasis to any region (bone etc.) having acute hemorrhage in the intracranial and / or lung and other areas having any contraindication to exercise training

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: severe-fatigued recipients<br>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. | |
| Group 2: non-severe-fatigued recipients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral muscle strength | Evaluated with a hand-held dynamometer | First day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walking test | Evaluated for specifing to functional exercise capacity | First day | 
| Respiratory muscle strength | Evaluated with a mouth pressure device | First day | 
| Pulmonary function test | Evaluated with a spirometer | 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. | 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). | First day | 
| Beck Depression Inventory-II (Turkish version) | Used for measurement of depression levels | 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. | First day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell transplantation, Fatigue, muscle strength, exercise capacity, Depression, Quality of Life