Clinical trial NCT03448471: Severe Fatigue in Stem Cell Transplantation
Official title: Pulmonary and Extra-pulmonary Characteristics in Severe-fatigued Allogeneic Hematopoietic Stem Cell Transplantation Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplantation
Fatigue
Keywords: stem cell transplantation
Fatigue
muscle strength
exercise capacity
Depression
Quality of Life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Peripheral muscle strength
timeFrame: First day
Secondary outcomes:
measure: 6-minute walking test
timeFrame: First day
measure: Respiratory muscle strength
timeFrame: First day
measure: Pulmonary function test
timeFrame: First day
measure: Fatigue Severity Scale
timeFrame: First day
measure: Modified Medical Research Council Dyspnea scale (MMRC)
timeFrame: First day
measure: Beck Depression Inventory-II (Turkish version)
timeFrame: First day
measure: European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
timeFrame: First day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Science Department of PhysioTherapy
Study officials:
affiliation: Gazi University
name: Gülşah Barğı, PhD.
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, PhD.
role: STUDY_DIRECTOR
affiliation: Bahçeşehir University
name: Gülsan Türköz Sucak, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paul KL. Rehabilitation and exercise considerations in hematologic malignancies. Am J Phys Med Rehabil. 2011 May;90(5 Suppl 1):S88-94. doi: 10.1097/PHM.0b013e31820be055.
citation: Soutar RL, King DJ. Bone marrow transplantation. BMJ. 1995 Jan 7;310(6971):31-6. doi: 10.1136/bmj.310.6971.31. No abstract available.
citation: Papadopoulos EB, Jakubowski AA. Novel approaches in allogeneic stem cell transplantation. Curr Oncol Rep. 2006 Sep;8(5):325-36. doi: 10.1007/s11912-006-0054-0.
citation: Wulff-Burchfield EM, Jagasia M, Savani BN. Long-term follow-up of informal caregivers after allo-SCT: a systematic review. Bone Marrow Transplant. 2013 Apr;48(4):469-73. doi: 10.1038/bmt.2012.123. Epub 2012 Jun 25.
citation: Polomeni A, Lapusan S, Bompoint C, Rubio MT, Mohty M. The impact of allogeneic-hematopoietic stem cell transplantation on patients' and close relatives' quality of life and relationships. Eur J Oncol Nurs. 2016 Apr;21:248-56. doi: 10.1016/j.ejon.2015.10.011. Epub 2015 Nov 18.
citation: Frodin U, Lotfi K, Fomichov V, Juliusson G, Borjeson S. Frequent and long-term follow-up of health-related quality of life following allogeneic haematopoietic stem cell transplantation. Eur J Cancer Care (Engl). 2015 Nov;24(6):898-910. doi: 10.1111/ecc.12350. Epub 2015 Jul 7.