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  • 1
    Keywords: CLINICAL-TRIALS ; BONE-MARROW-TRANSPLANTATION ; C-REACTIVE PROTEIN ; HIGH-DOSE CHEMOTHERAPY ; QUALITY-OF-LIFE ; VERSUS-HOST-DISEASE ; EUROPEAN-ORGANIZATION ; CANCER-RELATED FATIGUE ; MULTIMODAL INTERVENTION ; MUSCLE STRENGTH
    Abstract: BACKGROUND: Allogeneic stem cell transplantation (allo-HCT) is associated with high treatment-related mortality and innumerable physical and psychosocial complications and side-effects, such as high fatigue levels, loss of physical performance, infections, graft-versus-host disease (GvHD) and distress. This leads to a reduced quality of life, not only during and after transplantation, but also in the long term. Exercise interventions have been shown to be beneficial in allo-HCT patients. However, to date, no study has focused on long-term effects and survival. Previous exercise studies used 'usual care' control groups, leaving it unclear to what extent the observed effects are based on the physical effects of exercise itself, or rather on psychosocial factors such as personal attention. Furthermore, effects of exercise on and severity of GvHD have not been examined so far. We therefore aim to investigate the effects and biological mechanisms of exercise on side-effects, complications and survival in allo-HCT patients during and after transplantation. METHODS/DESIGN: The PETRA study is a randomized, controlled intervention trial investigating the effects of a yearlong partly supervised mixed exercise intervention (endurance and resistance exercises, 3-5 times per week) in 256 patients during and after allogeneic stem cell transplantation. Patients in the control group perform progressive muscle relaxation training (Jacobsen method) with the same frequency. Main inclusion criterion is planned allo-HCT. Main exclusion criteria are increased fracture risk, no walking capability or severe cardiorespiratory problems. Primary endpoint is overall survival after two years; secondary endpoints are non-relapse mortality, median survival, patient reported outcomes including cancer related fatigue and quality of life, physical performance, body composition, haematological/immunological reconstitution, inflammatory parameters, severity of complications and side-effects (e.g. GvHD and infections), and cognitive capacity. DISCUSSION: The PETRA study will contribute to a better understanding of the physiological and psychological effects of exercise training and their biological mechanisms in cancer patients after allo-HCT. The ultimate goal is the implementation of optimized intervention programs to reduce side-effects and improve quality of life and potentially prognosis after allogeneic stem cell transplantation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01374399 .
    Type of Publication: Journal article published
    PubMed ID: 26345187
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  • 2
    Keywords: DIAGNOSIS ; RISK ; PERFORMANCE ; COLORECTAL-CANCER ; BONE-MARROW-TRANSPLANTATION ; VERSUS-HOST-DISEASE ; IMMUNE FUNCTION ; BENEFITS ; COMORBIDITY INDEX ; MULTIMODAL INTERVENTION
    Abstract: Observational studies have suggested that physical activity may be associated with improved survival after cancer treatment. However, data from controlled clinical trials are required. We analyzed survival data of 103 patients from a previously published randomized controlled trial in allogeneic stem cell transplant patients who were randomized to either an exercise intervention (EX) or to a social contact control group. EX patients trained prior to hospital admission, during inpatient treatment, and for 6-8 weeks after discharge. Survival analyses were used to compare both total mortality (TM) and non-relapse mortality (NRM) after discharge and transplantation during an observation period of 2 years after transplantation. Analyses were corroborated with Cox and Fine & Gray regression models adjusting for potential confounders. After discharge, EX patients had a significantly lower TM rate than controls (12.0 vs. 28.3%, p = 0.030) and a numerically lower NRM rate (4.0 vs. 13.5%, p = 0.086). When the inpatient period was included, absolute risk reductions were similar but not significantly different (TM: 34.0 vs. 50.9%, p = 0.112; NRM: 26.0 vs. 36.5%, p = 0.293). The number needed to treat (NNT) to prevent one death with EX was about 6. Furthermore, regression analyses revealed that baseline fitness was protective against mortality. The data suggest that exercise might improve survival in patients undergoing allo-HCT. However, the results should be interpreted with caution as the study was not designed to detect differences in survival rates, and as no stratification on relevant prognostic factors was carried out.
    Type of Publication: Journal article published
    PubMed ID: 26061092
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  • 3
    ISSN: 1433-8491
    Keywords: Key words Depression ; Bipolar disorder ; Lithium ; Prophylaxis ; Efficacy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract It has been reported recently that the prophylactic efficacy of lithium is a transient phenomenon in many patients. Other studies suggest sustained efficacy against affective recurrences for many years. As this issue is of major therapeutic relevance, published literature considering changes in lithium efficacy over time has been reviewed. The present review includes a critical evaluation of the data and the methodology which yielded these controversial results. Considering the published data discussed in this review, the balance of evidence does not indicate a general loss of lithium efficacy in the prophylaxis of major affective disorders. A supposed persistence of the prophylactic effects in general does not, however, exclude the reappearance of affective recurrences after years of successful treatment in individual cases. Possible reasons for this phenomenon are discussed.
    Type of Medium: Electronic Resource
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