Severe Fatigue in Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physical Impairments in Allogeneic-HSCT

NCT03448627

Stem Cell Transplantation

COMPLETED

Physical Deteriorations in Allo-HSCT.

NCT03606005

Stem Cell Transplantation

COMPLETED

Physical Impairments Related to Myeloid and Lymphoid Malignancies

NCT03699358

Stem Cell Transplantation

COMPLETED

Physical Functions in Allogeneic-HSCT Candidates

NCT03915249

Stem Cell Transplantation

COMPLETED

Intervention for Fatigue in HCT Recipients

NCT05715047

Hematologic Cancer Hematologic Malignancy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stem Cell Transplantation Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: severe-fatigued recipients

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.

No interventions assigned to this group

Group 2: non-severe-fatigued recipients

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No