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| ID | Type | Description | Link |
|---|---|---|---|
| S-06187 (REK Sør) | Other Identifier | REK Sør | |
| 2006-18 (RRHF) | Other Identifier | Oslo University Hospital |
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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Norwegian Cancer Society | OTHER |
| The Research Council of Norway | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tomato |
|
| 2 | Experimental | Multi-diet |
|
| 3 | Active Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate cancer, phytochemical and PUFA | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| serum prostate specific antigen | Baseline, after intervention, follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| oxidative stress biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up | |
| antioxidant status biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Lilleby, MD | Rikshospitalet-Radiumhospitalet, Oslo | Principal Investigator |
| Sigbjørn Smeland, MD, PhD. | Rikshospitalet-Radiumhospitalet, Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Universuty Hospital, Radiumhospitalet and Aker | Oslo | 0310 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27406859 | Derived | Paur I, Lilleby W, Bohn SK, Hulander E, Klein W, Vlatkovic L, Axcrona K, Bolstad N, Bjoro T, Laake P, Tasken KA, Svindland A, Eri LM, Brennhovd B, Carlsen MH, Fossa SD, Smeland SS, Karlsen AS, Blomhoff R. Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clin Nutr. 2017 Jun;36(3):672-679. doi: 10.1016/j.clnu.2016.06.014. Epub 2016 Jun 30. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064209 | Phytochemicals |
| D005231 | Fatty Acids, Unsaturated |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| oxidative damage biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
| inflammation biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
| Apoptose markers in prostate tissue | Baseline, after intervention, follow-up |
| DNA microarrays in blood cells and prostate tissue | Baseline, after intervention, follow-up |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |