Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04167683

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Hematologic Diseases Acute Lymphoid Leukemia Acute Myeloid Leukemia Bone Marrow Diseases Chronic Disease Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Non Hodgkin Lymphoma Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Stem Cell Transplant Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Cohort 1 and Cohort 2 Medical treatment complications

    Time frame: 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 outcomes

  1. Hospitalization duration

    Time frame: From baseline to 1 year follow-up

    Total number days in hospital

  2. Disease free survival

    Time frame: From baseline to 1 year follow-up

    Risk of disease progression

  3. Overall survival

    Time frame: From baseline to 1 year follow-up

    Risk of mortality from any-cause

  4. Change in whole body lean mass

    Time frame: From baseline to 1 year follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  5. Change in appendicular lean mass

    Time frame: From baseline to 1 year follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  6. Change in whole body fat percentage

    Time frame: From baseline to 1 year follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  7. Change in visceral fat mass

    Time frame: From baseline to 1 year follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  8. Change in bone mineral density

    Time frame: From baseline to 1 year follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  9. Change in bone mineral content

    Time frame: From baseline to 1 year follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  10. Change in walking capacity

    Time frame: From baseline to 1 year follow-up

    Maximum 10 meter walking speed

  11. Change in lower body physical function

    Time frame: From baseline to 1 year follow-up

    30 seconds Sit-To- Stand test

  12. Change in maximum leg power

    Time frame: From baseline to 1 year follow-up

    Leg extensor power test

  13. Change in inflammation markers

    Time frame: 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

  14. Change in creatinine and hemoglobin

    Time frame: 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

  15. Change in body fat percentage, fat mass, fat-free mass, muscle mass and bone mass and total body water

    Time frame: From baseline to 1 year follow-up

    Bioelectrical Impedance Analyzer

  16. Change in health related quality of life

    Time frame: 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)

  17. Change in psychological distress

    Time frame: From baseline to 1 year follow-up

    Hospital Anxiety and Depression Scale (HADS) questionnaire

  18. Change in sleep quality

    Time frame: From baseline to 1 year follow-up

    Pittsburgh Sleep Quality Index (PSQI) questionnaire

  19. Change in physical activity level

    Time frame: From baseline to 1 year follow-up

    International Physical Activity Questionnaire (IPAQ) short form

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2019
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.