Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant

Rigshospitalet

Status: Enrolling

Conditions: Acute Lymphoid Leukemia; Stem Cell Transplant Complications; Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma; Myelodysplastic Syndromes; Acute Myeloid Leukemia; Hematologic Diseases

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04167683

P-2019-223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

144 participants in 2 patient groups

Cohort 1 - Patients referred to myeloablative HSCT

Description:

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.

Treatment:

Other: No intervention

Cohort 2 - Patients referred to non myeloablative HSCT

Description:

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.

Treatment:

Other: No intervention