Allogeneic Stem Cell Transplantation
Conditions
Keywords
allogeneic stem cell transplantation, exercise, survival, fatigue, quality of life, cancer, physical performance
Brief summary
The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation. The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.
Interventions
BEHAVIORALexercise and relaxation
resistance and endurance exercise, 3-5 times per week
Sponsors
National Center for Tumor Diseases, Heidelberg
University Hospital Heidelberg
Central Institute of Mental Health, Mannheim
German Cancer Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical indication: allogeneic stem cell transplantation
Exclusion criteria
* Orthopeadic limitations that hamper the exercise intervention * Osseous degenerations that have an improved fracture risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation | mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29) |
| Hemoglobin, Leukocytes, Thrombocytes | during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation | Hematological and immunological reconstitution |
| Side-effects (Infections, GvHD, Depression, Distress) | during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation | Depression mesured by Allgemeine Depressionskala (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) Distress mesures by the NCCN Distress Thermometer |
| Adherence to exercise protocol | one year | Fesability of an one-year exercise intervention after allogeneic HSCT |
| Fatigue | admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation | measured by the Multidimensional Fatique Inventory (MFI) |
| cardiorespiratory fitness | admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation | measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters) |
| IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin | admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation | Biomarker in blood and urine |
| median survival, non-relapse mortality | admission to hospital until 2 years after transplantation | — |
| Muscular strength | admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation | measured at the IsoMed2000 and/or Handheld Dynamometer |
Countries
Germany
Outcome results
None listed