The Effect of Medical Treatment on Muscle Dysfunction and the Prognostic Role of Muscle Dysfunction at Critical Decision Points in Patients With Hematological Diseases Referred to Myeloablative Hematopoietic Stem Cell Transplant (HSCT), to Myeloablative HSCT With a "Reduced Toxicity Conditioning" Regime With Fludarabine and Treosulfane (FluTreo), or to Non-myeloablative HSCT. - A Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Cohort 1 and Cohort 2 Medical treatment complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •age <18; pregnancy; physical or mental disabilities precluding test of muscle function; inability to read and understand Danish
结局指标
主要结局
Cohort 1 and Cohort 2 Medical treatment complications
时间窗: 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)
次要结局
- Change in visceral fat mass(From baseline to 1 year follow-up)
- Disease free survival(From baseline to 1 year follow-up)
- Overall survival(From baseline to 1 year follow-up)
- Change in whole body lean mass(From baseline to 1 year follow-up)
- Change in appendicular lean mass(From baseline to 1 year follow-up)
- Change in whole body fat percentage(From baseline to 1 year follow-up)
- Hospitalization duration(From baseline to 1 year follow-up)
- Change in bone mineral density(From baseline to 1 year follow-up)
- Change in bone mineral content(From baseline to 1 year follow-up)
- Change in walking capacity(From baseline to 1 year follow-up)
- Change in lower body physical function(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(From baseline to 1 year follow-up)
- Change in psychological distress(From baseline to 1 year follow-up)
- Change in sleep quality(From baseline to 1 year follow-up)
- Change in maximum leg power(From baseline to 1 year follow-up)
- Change in inflammation markers(From baseline to 1 year follow-up)
- Change in creatinine and hemoglobin(From baseline to 1 year follow-up)
- Change in health related quality of life(From baseline to 1 year follow-up)
- Change in physical activity level(From baseline to 1 year follow-up)
研究者
Jan Christensen
post doc
Rigshospitalet, Denmark