Prostate Cancer Clinical Trial
Official title:
Prostate Phytochemical & PUFA Intervention - a Phase I/II Study
We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues
A total of 102 patients with localized prostate cancer will be included in the study. A the
time of inclusion, the participants will be randomized to three groups.
The intervention groups includes; control group, tomato group and multi-diet group. The
intervention period is three week and will be completed before prostatectomy or radiation
therapy.
Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other
inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E,
glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress
markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin
C, total lipidperoxides (d-ROM) and protein carbonyls.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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