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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04167683

Collaborator

(none)

144

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases Chronic Myeloid Leukemia Acute Myeloid Leukemia Acute Lymphoid Leukemia Myelodysplastic Syndromes Non Hodgkin Lymphoma Stem Cell Transplant Complications Chronic Lymphocytic Leukemia	Other: No intervention

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

144 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 - Patients referred to myeloablative HSCT 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.	Other: No intervention No intervention
Cohort 2 - Patients referred to non myeloablative HSCT 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.	Other: No intervention No intervention

Arm

Intervention/Treatment

Cohort 1 - Patients referred to myeloablative HSCT

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.

Other: No intervention

No intervention

Cohort 2 - Patients referred to non myeloablative HSCT

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

Cohort 1 and Cohort 2 Medical treatment complications [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 Outcome Measures

Hospitalization duration [From baseline to 1 year follow-up]
Total number days in hospital
Disease free survival [From baseline to 1 year follow-up]
Risk of disease progression
Overall survival [From baseline to 1 year follow-up]
Risk of mortality from any-cause
Change in whole body lean mass [From baseline to 1 year follow-up]
Dual-energy X-ray Absorptiometry (DXA) scan
Change in appendicular lean mass [From baseline to 1 year follow-up]
Dual-energy X-ray Absorptiometry (DXA) scan
Change in whole body fat percentage [From baseline to 1 year follow-up]
Dual-energy X-ray Absorptiometry (DXA) scan
Change in visceral fat mass [From baseline to 1 year follow-up]
Dual-energy X-ray Absorptiometry (DXA) scan
Change in bone mineral density [From baseline to 1 year follow-up]
Dual-energy X-ray Absorptiometry (DXA) scan
Change in bone mineral content [From baseline to 1 year follow-up]
Dual-energy X-ray Absorptiometry (DXA) scan
Change in walking capacity [From baseline to 1 year follow-up]
Maximum 10 meter walking speed
Change in lower body physical function [From baseline to 1 year follow-up]
30 seconds Sit-To- Stand test
Change in maximum leg power [From baseline to 1 year follow-up]
Leg extensor power test
Change in inflammation markers [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
Change in creatinine and hemoglobin [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
Change in body fat percentage, fat mass, fat-free mass, muscle mass and bone mass and total body water [From baseline to 1 year follow-up]
Bioelectrical Impedance Analyzer
Change in health related quality of life [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)
Change in psychological distress [From baseline to 1 year follow-up]
Hospital Anxiety and Depression Scale (HADS) questionnaire
Change in sleep quality [From baseline to 1 year follow-up]
Pittsburgh Sleep Quality Index (PSQI) questionnaire
Change in physical activity level [From baseline to 1 year follow-up]
International Physical Activity Questionnaire (IPAQ) short form

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.