Investigating muscle dysfunction in patients with blood cancers before 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.
This study looks at how blood cancers and stem cell transplants affect muscle strength and health in patients to see how it impacts their treatment and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | Fludarabine |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT04167683 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of hematological diseases and hematopoietic stem cell transplant (HSCT) on muscle dysfunction in patients. It focuses on assessing muscle mass and strength, as well as patient-reported outcomes, to understand how these factors influence prognosis and treatment efficacy. The study will evaluate changes in body composition from the point of referral to HSCT and throughout the cancer continuum, providing insights into the relationship between muscle health and cancer outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with specific hematological malignancies referred for HSCT at Rigshospitalet.
Not a fit: Patients under 18, pregnant women, or those with disabilities that prevent muscle function testing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and treatment strategies for patients with hematological diseases undergoing HSCT.
How similar studies have performed: While the specific focus on muscle dysfunction in this context may be novel, related studies have indicated the importance of body composition in cancer prognosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Jan Christensen, post doc — Department of Occupational- and Physiotherapy, Rigshospitalet
- Study coordinator: Jan Christensen, post doc
- Email: jan.christensen.02@regionh.dk
- Phone: 0045 22479075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.