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

Acute Myeloid Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167683
• Other study ID #: P-2019-223
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Myeloid Leukemia
• Hematologic Diseases
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Myelodysplastic Syndromes
• Non Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Stem Cell Transplant Complications

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