Trials / Active Not Recruiting
Active Not RecruitingNCT04167683
Muscle Dysfunction in Patients With Hematological Diseases Referred to Stem Cell Transplant
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.
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 144 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Hematologic Diseases
- Chronic Myeloid Leukemia
- Acute Myeloid Leukemia
- Acute Lymphoid Leukemia
- Myelodysplastic Syndromes
- Non Hodgkin Lymphoma
- Stem Cell Transplant Complications
- Chronic Lymphocytic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention | No intervention |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2019-11-19
- Last updated
- 2025-12-08
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04167683. Inclusion in this directory is not an endorsement.