Fatigue Clinical Trial - Severe Fatigue in Stem Cell Transplantation

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03448471
Study type	Observational
Source	Gazi University
Contact
Status	Completed
Phase	N/A
Start date	March 2012
Completion date	December 2017

View Details

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