Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia, Hematologic Diseases, Myelodysplastic Syndromes, Non Hodgkin Lymphoma, Stem Cell Transplant Complications
Conditions
Keywords
Muscle mass, Muscle strength, Complications, Patient reported outcomes, PRO, Physical function, hematopoietic stem cell transplant
Brief summary
PURPOSE: To investigate the effect of the disease and HSCT on muscle dysfunction and to investigate the prognostic role of muscle dysfunction at critical decision points in patients with hematological diseases referred to hematopoietic stem cell transplant (HSCT). HSCT: Patients diagnosed with malignant hematological diseases who are referred to myeloablative HSCT, to a myeloablative reduced toxicity conditioning regime with Fludarabine and Treosulfane (FluTreo) or to non-myeloablative HSCT.
Detailed description
RATIONAL: Patients diagnosed with malignant hematological diseases undergoing HSCT are faced with poor prognosis. The treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. To what extend patients body composition at the point of referral to HSCT, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long term prognosis.
Interventions
OTHERNo intervention
No intervention
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with acute myelogenous leukaemia (AML), acute lymphatic leukaemia (ALL), chronic myelomonocytic leukaemia (CMML), myelodysplastic syndrome (MDS), chronic lymphatic leukaemia (CLL), malignant lymphomas or multiple myeloma (MM) referred to myeloablative HSCT, myeloablative RTC-HSCT or non-myeloablative HSCT at the Department of Haematology, Rigshospitalet, Blegdamsvej.
Exclusion criteria
* age \<18; pregnancy; physical or mental disabilities precluding test of muscle function; inability to read and understand Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1 and Cohort 2 Medical treatment complications | From baseline to 1 year follow-up | Incidens rate of medical complications (mortality, re-hospitalization, infections, all cause disease relapse, chronic GVHD, return to work) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | From baseline to 1 year follow-up | Risk of disease progression |
| Overall survival | From baseline to 1 year follow-up | Risk of mortality from any-cause |
| Change in whole body lean mass | From baseline to 1 year follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in appendicular lean mass | From baseline to 1 year follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in whole body fat percentage | From baseline to 1 year follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in visceral fat mass | From baseline to 1 year follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in bone mineral density | From baseline to 1 year follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in bone mineral content | From baseline to 1 year follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in walking capacity | From baseline to 1 year follow-up | Maximum 10 meter walking speed |
| Hospitalization duration | From baseline to 1 year follow-up | Total number days in hospital |
| Change in maximum leg power | From baseline to 1 year follow-up | Leg extensor power test |
| Change in inflammation markers | From baseline to 1 year follow-up | Blood values are registered from the patients hospital record in relation to assessments. C-reactive protein (CRP) and leucocytes are registered as they are inflammation markers |
| Change in creatinine and hemoglobin | From baseline to 1 year follow-up | Blood values are registered from the patients hospital record in relation to assessments. C-reactive protein (CRP) and leucocytes are registered as they have an influence on muscle strength |
| Change in body fat percentage, fat mass, fat-free mass, muscle mass and bone mass and total body water | From baseline to 1 year follow-up | Bioelectrical Impedance Analyzer |
| Change in health related quality of life | From baseline to 1 year follow-up | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 Version 3.0) |
| Change in psychological distress | From baseline to 1 year follow-up | Hospital Anxiety and Depression Scale (HADS) questionnaire |
| Change in sleep quality | From baseline to 1 year follow-up | Pittsburgh Sleep Quality Index (PSQI) questionnaire |
| Change in physical activity level | From baseline to 1 year follow-up | International Physical Activity Questionnaire (IPAQ) short form |
| Change in lower body physical function | From baseline to 1 year follow-up | 30 seconds Sit-To- Stand test |
Countries
Denmark
Outcome results
None listed