Clinical trial NCT04167683: Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Diseases
Chronic Myeloid Leukemia
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Myelodysplastic Syndromes
Non Hodgkin Lymphoma
Stem Cell Transplant Complications
Chronic Lymphocytic Leukemia
Keywords: Muscle mass
Muscle strength
Complications
Patient reported outcomes
PRO
Physical function
hematopoietic stem cell transplant
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant hematological diseases referred to myeloablative HSCT, myeloablative RTC-HSCT or non-myeloablative HSCT.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohort 1 and Cohort 2 Medical treatment complications
timeFrame: From baseline to 1 year follow-up
Secondary outcomes:
measure: Hospitalization duration
timeFrame: From baseline to 1 year follow-up
measure: Disease free survival
timeFrame: From baseline to 1 year follow-up
measure: Overall survival
timeFrame: From baseline to 1 year follow-up
measure: Change in whole body lean mass
timeFrame: From baseline to 1 year follow-up
measure: Change in appendicular lean mass
timeFrame: From baseline to 1 year follow-up
measure: Change in whole body fat percentage
timeFrame: From baseline to 1 year follow-up
measure: Change in visceral fat mass
timeFrame: From baseline to 1 year follow-up
measure: Change in bone mineral density
timeFrame: From baseline to 1 year follow-up
measure: Change in bone mineral content
timeFrame: From baseline to 1 year follow-up
measure: Change in walking capacity
timeFrame: From baseline to 1 year follow-up
measure: Change in lower body physical function
timeFrame: From baseline to 1 year follow-up
measure: Change in maximum leg power
timeFrame: From baseline to 1 year follow-up
measure: Change in inflammation markers
timeFrame: From baseline to 1 year follow-up
measure: Change in creatinine and hemoglobin
timeFrame: From baseline to 1 year follow-up
measure: Change in body fat percentage, fat mass, fat-free mass, muscle mass and bone mass and total body water
timeFrame: From baseline to 1 year follow-up
measure: Change in health related quality of life
timeFrame: From baseline to 1 year follow-up
measure: Change in psychological distress
timeFrame: From baseline to 1 year follow-up
measure: Change in sleep quality
timeFrame: From baseline to 1 year follow-up
measure: Change in physical activity level
timeFrame: From baseline to 1 year follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department of Occupational- and Physiotherapy, Rigshospitalet
name: Jan Christensen, post doc
role: PRINCIPAL_INVESTIGATOR
References: