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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Patients referred to myeloablative HSCT | These patients will undergo 5 assessments: a baseline-assessment 3-4 week prior to conditioning treatment, at discharge (in-patients) or at day +28 after stem cell infusion (out-patients) and follow-up assessments at 3 months, 6 months and 12 months. |
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| Cohort 2 - Patients referred to non myeloablative HSCT | These patients will undergo 5 assessments: a baseline-assessment 3-4 week prior to conditioning treatment, at discharge (in-patients) or at day +28 after stem cell infusion (out-patients) and follow-up assessments at 3 months, 6 months and 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 and Cohort 2 Medical treatment complications | Incidens rate of medical complications (mortality, re-hospitalization, infections, all cause disease relapse, chronic GVHD, return to work) | From baseline to 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization duration | Total number days in hospital | From baseline to 1 year follow-up |
| Disease free survival | Risk of disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with malignant hematological diseases referred to myeloablative HSCT, myeloablative RTC-HSCT or non-myeloablative HSCT.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Christensen, post doc | Department of Occupational- and Physiotherapy, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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| From baseline to 1 year follow-up |
| Overall survival | Risk of mortality from any-cause | From baseline to 1 year follow-up |
| Change in whole body lean mass | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 1 year follow-up |
| Change in appendicular lean mass | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 1 year follow-up |
| Change in whole body fat percentage | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 1 year follow-up |
| Change in visceral fat mass | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 1 year follow-up |
| Change in bone mineral density | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 1 year follow-up |
| Change in bone mineral content | Dual-energy X-ray Absorptiometry (DXA) scan | From baseline to 1 year follow-up |
| Change in walking capacity | Maximum 10 meter walking speed | From baseline to 1 year follow-up |
| Change in lower body physical function | 30 seconds Sit-To- Stand test | From baseline to 1 year follow-up |
| Change in maximum leg power | Leg extensor power test | From baseline to 1 year follow-up |
| Change in inflammation markers | 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 | From baseline to 1 year follow-up |
| Change in creatinine and hemoglobin | 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 | From baseline to 1 year follow-up |
| Change in body fat percentage, fat mass, fat-free mass, muscle mass and bone mass and total body water | Bioelectrical Impedance Analyzer | From baseline to 1 year follow-up |
| Change in health related quality of life | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 Version 3.0) | From baseline to 1 year follow-up |
| Change in psychological distress | Hospital Anxiety and Depression Scale (HADS) questionnaire | From baseline to 1 year follow-up |
| Change in sleep quality | Pittsburgh Sleep Quality Index (PSQI) questionnaire | From baseline to 1 year follow-up |
| Change in physical activity level | International Physical Activity Questionnaire (IPAQ) short form | From baseline to 1 year follow-up |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D015448 | Leukemia, B-Cell |
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