Severe Fatigue in Stem Cell Transplantation

March 8, 2018 updated by: Meral Boşnak Güçlü, Gazi University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Gazi University Faculty of Health Science Department of PhysioTherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Chair: Gülşah Barğı, PhD., Gazi University
  • Study Director: Meral Boşnak Güçlü, PhD., Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziUniversity4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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