Oslo Universuty Hospital, Radiumhospitalet and Aker
Oslo, 0310, Norway
NCT Number: NCT00433797
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
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Interventional
Phase 1 / Phase 2
Oslo, 0310, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
Other names: PFPI
Time frame: Baseline, after intervention, follow-up
Time frame: Baseline, after intervention, follow-up
Time frame: Baseline, after intervention, follow-up
Time frame: Baseline, after intervention, follow-up
Time frame: Baseline, after intervention, follow-up
Time frame: Baseline, after intervention, follow-up
Time frame: Baseline, after intervention, follow-up
University of Oslo
Other
Prostate Phytochemical & PUFA Intervention - a Phase I/II Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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