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Completed

NCT Number: NCT03448471

Severe Fatigue in Stem Cell Transplantation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Science Department of PhysioTherapy

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Peripheral muscle strength

    Time frame: First day

    Evaluated with a hand-held dynamometer

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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