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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04167683
Other study ID # P-2019-223
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Rigshospitalet, Denmark
Contact Jan Christensen, post doc
Phone 0045 22479075
Email jan.christensen.02@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Hospitalization duration Total number days in hospital From baseline to 1 year follow-up
Secondary Disease free survival Risk of disease progression From baseline to 1 year follow-up
Secondary Overall survival Risk of mortality from any-cause From baseline to 1 year follow-up
Secondary Change in whole body lean mass Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 1 year follow-up
Secondary Change in appendicular lean mass Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 1 year follow-up
Secondary Change in whole body fat percentage Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 1 year follow-up
Secondary Change in visceral fat mass Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 1 year follow-up
Secondary Change in bone mineral density Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 1 year follow-up
Secondary Change in bone mineral content Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 1 year follow-up
Secondary Change in walking capacity Maximum 10 meter walking speed From baseline to 1 year follow-up
Secondary Change in lower body physical function 30 seconds Sit-To- Stand test From baseline to 1 year follow-up
Secondary Change in maximum leg power Leg extensor power test From baseline to 1 year follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change in psychological distress Hospital Anxiety and Depression Scale (HADS) questionnaire From baseline to 1 year follow-up
Secondary Change in sleep quality Pittsburgh Sleep Quality Index (PSQI) questionnaire From baseline to 1 year follow-up
Secondary Change in physical activity level International Physical Activity Questionnaire (IPAQ) short form From baseline to 1 year follow-up
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