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Severe Fatigue in Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448471
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

Study Description
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Brief 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.

Condition or disease
Stem Cell Transplantation Fatigue

Detailed 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
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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pulmonary and Extra-pulmonary Characteristics in Severe-fatigued Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Study Start Date : March 2012
Actual Primary Completion Date : August 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Groups and Cohorts
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Group/Cohort
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Peripheral muscle strength [ Time Frame: First day ]
    Evaluated with a hand-held dynamometer


Secondary Outcome Measures :
  1. 6-minute walking test [ Time Frame: First day ]
    Evaluated for specifing to functional exercise capacity

  2. Respiratory muscle strength [ Time Frame: First day ]
    Evaluated with a mouth pressure device

  3. Pulmonary function test [ Time Frame: First day ]
    Evaluated with a spirometer

  4. Fatigue Severity Scale [ 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.

  5. Modified Medical Research Council Dyspnea scale (MMRC) [ 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).

  6. Beck Depression Inventory-II (Turkish version) [ Time Frame: First day ]
    Used for measurement of depression levels

  7. European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL) [ 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448471


Locations
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Turkey
Gazi University Faculty of Health Science Department of PhysioTherapy
Ankara, Turkey, 06010
Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Gülşah Barğı, PhD. Gazi University
Study Director: Meral Boşnak Güçlü, PhD. Gazi University
Principal Investigator: Gülsan Türköz Sucak, PhD. Bahçeşehir University
More Information
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Publications of Results:

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Responsible Party: Meral Boşnak Güçlü, Assoc. Prof., Gazi University
ClinicalTrials.gov Identifier: NCT03448471    
Other Study ID Numbers: GaziUniversity4
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meral Boşnak Güçlü, Gazi University:
stem cell transplantation
Fatigue
muscle strength
 exercise capacity
Depression
Quality of Life
Additional relevant MeSH terms:
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Fatigue