1. Patient initiation rate (Time Frame - 12 weeks): Study initiation rate (total number of patients enrolled divided by the number of patients screened for the study)
2. Patient retention rate (Time Frame - 12 weeks): Retention rate (number of patients completing the study divided by total number of patients enrolled at baseline)
3. Adherence to prescribed training program (Time Frame - 12 weeks): Adherence rate (fraction of scheduled physical activity appointments/selftrainings attended/carried out by the patients)
4. Adherence to prescribed dietary regimen (Time Frame - 12 weeks): Adherence rate (fraction of days of adherence to the prescribed dietary regimen)
Secondary outcome:
1. Effect of lifestyle intervention on PSA progression (Time Frame - 24 weeks): Percentage of PSA non-progressors (patients with <25% PSA rise compared to baseline) at weeks 8, 12 and 24
2. Effect of lifestyle intervention on PSA levels (Time Frame - 24 weeks): PSA doubling time calculated with the formula PSA doubling time = ln (2) / PSA Slope [PSA Slope = (ln (PSA level 2) - ln (PSA level 1)) / Time (no. of months)]
3. Effect of lifestyle intervention on radiographic progression (Time Frame - 24 weeks): Percentage of patients being free of radiographic progression according to PCWG3 at weeks 12 and 24
4. Effect of lifestyle intervention on patient-reported quality of life (Time Frame - 24 weeks): Change in patient-reported quality of life from baseline using Functional Assessment of Cancer Therapy - Prostate (FACT-P) scoring from baseline to weeks 8, 12 and 24
5. Effect of lifestyle intervention on patient-reported fatigue (Time Frame - 24 weeks): Change in patient-reported fatigue from baseline using FACIT Fatigue scoring from baseline to weeks 8, 12 and 24
6. Effect of lifestyle intervention on time to subsequent treatment (Time Frame - 24 months): Time to a subsequent line of treatment (in weeks)
7. Effect of lifestyle intervention on plasma lipid signature (Time Frame - 8 weeks): Concentration of individual lipid types in the plasma of participating patients, change compared to baseline
8. Effect of lifestyle intervention on plasma immune signature (Time Frame - 8 weeks): Concentration of inflammatory cytokines in the plasma of participating patients, change compared to baseline
9. Effect of lifestyle intervention on microbiome composition (Time Frame - 8 weeks): Differences in community diversity and/or abundance of specific bacterial taxa within the intestinal microbiome prior to or during the lifestyle intervention.
10. Effect of lifestyle intervention on anthropometric variables (Time Frame - 24 weeks): Measurement of patient height and body weight and calculation of body-mass index (BMI) at baseline, during and after the lifesyle intervention.
11. Effect of lifestyle intervention on lean body mass (Time Frame - 12 weeks): Measurement of the percentage of lean body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
12. Effect of lifestyle intervention on fat body mass (Time Frame - 12 weeks): Measurement of the percentage of fat body mass by bioelectrical impedance vector analysis and by magnetic resonance imaging.
Lifestyle intervention: 12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training).
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Lifestyle Intervention in Patients With Metastatic Prostate Cancer"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!