Severe Fatigue in Stem Cell Transplantation

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448471
• Other study ID #: GaziUniversity4
• Status: Completed
• Phase: N/A
• First received: February 22, 2018
• Last updated: March 8, 2018
• Start date: March 2012
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Stem Cell Transplantation

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Science Department of PhysioTherapy	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Frödin U, Lotfi K, Fomichov V, Juliusson G, Börjeson 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.12 — View Citation

Papadopoulos EB, Jakubowski AA. Novel approaches in allogeneic stem cell transplantation. Curr Oncol Rep. 2006 Sep;8(5):325-36. Review. — View 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. Review. — View Citation

Poloméni 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.2015.10.0 — View Citation

Soutar RL, King DJ. Bone marrow transplantation. BMJ. 1995 Jan 7;310(6971):31-6. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral muscle strength	Evaluated with a hand-held dynamometer	First day
Secondary	6-minute walking test	Evaluated for specifing to functional exercise capacity	First day
Secondary	Respiratory muscle strength	Evaluated with a mouth pressure device	First day
Secondary	Pulmonary function test	Evaluated with a spirometer	First day
Secondary	Fatigue Severity Scale	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
Secondary	Modified Medical Research Council Dyspnea scale (MMRC)	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
Secondary	Beck Depression Inventory-II (Turkish version)	Used for measurement of depression levels	First day
Secondary	European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)	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