Pilot Study on the Impact of a Home-Based Exercise Program on Inflammatory Cytokines and Quality of Life in Men with Prostate Cancer Under Active Surveillance.

OBJECTIVES: This study aimed to demonstrate potential translation of pre-clinical studies to a home-based exercise intervention in mediating inflammatory cytokine markers and tumor progression in men under active surveillance for prostate cancer. METHODS: A 2-arm randomized control parallel group design was used. The exercise intervention consisted of 24 weeks of an aerobic and resistance home-based exercise program and results were compared to a waitlist control group. Data were collected at baseline and end of study for eotaxin, interferon-γ (INF-γ), interleukin-12 (IL-12), interleukin-1α (IL-1α), interleukin-5 (IL-5), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF), distanced walked during a 6-minute walk test (6MWT), body mass index, and health-related quality of life. RESULTS: Non-significant decreases were observed in all biomarkers, especially VEGF (pre: 125.16 ± 198.66, post: 80.29 ± 124.30, P = .06) and INF-γ (pre: 152.88 ± 312.71, post: 118.93 ± 158.79, P = .08), in the intervention group; only IL- α (pre: 332.15 ± 656.77, post: 255.12 ± 502.09, P = .20) decreased in the control group while all other biomarkers increased from baseline to end of study. A non-significant increase in 6MWT distance was observed in the intervention group, while a decrease was seen in the control group. Significant decreases in physical function, emotional wellbeing, and total composite scale on the FACIT-F were observed in the intervention group, possibly due to the isolation restrictions of COVID-19. Physical function on the SF-36 significantly increased in the control group. CONCLUSIONS: Future studies with powered samples are needed to confirm the trends observed for inflammatory biomarkers and functional fitness.

A randomized controlled trial of a home-based exercise program on prognostic biomarkers in men with prostate cancer: A study protocol.

BACKGROUND: Herein, we propose a novel RCT study to collect preliminary data on the impact of a 24-week home-based exercise program that can improve prognosis, physical function, and quality of life (QoL) in men with prostate cancer (PCa). This study will provide data on the feasibility of conducting a home-based exercise study and pilot data on the impact of exercise on circulating concentrations of biomarkers reported in the literature to be beneficial for the prognostication of PCa. METHODS/DESIGN: Thirty male patients, clinically-diagnosed with prostate cancer under active surveillance, will be recruited to participate in a 2-arm, 24-week home-based program. Random allocation to each arm - intervention, and control - will be performed in a 1:1 ratio. Participants assigned to the intervention group will perform 30 min of light-to-moderate intensity walking five days a week (40-60% heart rate reserve) and three sets of 15 repetitions of light callisthenic exercises (bodyweight squats, incline push-ups, and hip thrusts) 3 days a week. Participants randomized to the control group will maintain normal activity throughout the 24 weeks. Four visits occurring at baseline, 12-, 18-, and 24-weeks will be used to assess QoL, body composition, prognostic biomarker concentrations, and overall physical function. Primary endpoints include significant changes in prognostic biomarkers. Secondary endpoints include changes in quality of life, physical function and body composition. DISCUSSION: This study should demonstrate preliminary evidence that a home-based exercise intervention can impact biomarkers of progression while improving quality of life, physical function and body composition. Results from this study have the potential to promote health and wellness while minimizing cancer progression in men with PCa.