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Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433797
First Posted: February 12, 2007
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oslo University Hospital
Norwegian Cancer Society
The Research Council of Norway
Information provided by (Responsible Party):
Rune Blomhoff, University of Oslo
  Purpose
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

Condition Intervention Phase
Prostate Cancer Dietary Supplement: Prostate cancer, phytochemical and PUFA Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Resource links provided by NLM:


Further study details as provided by Rune Blomhoff, University of Oslo:

Primary Outcome Measures:
  • serum prostate specific antigen [ Time Frame: Baseline, after intervention, follow-up ]

Secondary Outcome Measures:
  • oxidative stress biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ]
  • antioxidant status biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ]
  • oxidative damage biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ]
  • inflammation biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ]
  • Apoptose markers in prostate tissue [ Time Frame: Baseline, after intervention, follow-up ]
  • DNA microarrays in blood cells and prostate tissue [ Time Frame: Baseline, after intervention, follow-up ]

Enrollment: 86
Study Start Date: June 2007
Study Completion Date: December 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tomato
Dietary Supplement: Prostate cancer, phytochemical and PUFA
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 Name: PFPI
Experimental: 2
Multi-diet
Dietary Supplement: Prostate cancer, phytochemical and PUFA
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 Name: PFPI
Active Comparator: 3
Control
Dietary Supplement: Prostate cancer, phytochemical and PUFA
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 Name: PFPI

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenoarcinoma (as confirmed by histology)
  • pN0/NXM0 (TNM/UICC 2002) and at least one negative prognosis factor for HDR-BT or low risk profile with the use of radical prostatectomy.
  • Serum PSA< 20 ng/mL, and Gleason score =>6 or T1c- T3a, prostate volume < 60mL
  • Performance status 0-1
  • Normal WBC and thromocytes, Hb >11g/dl

Exclusion Criteria:

  • No previous endocrine treatment
  • Life expectancy > 5 år
  • No possible co-morbidity (CVD, COPD, diabetes type I, vasculatory syndromes or inflammatory diseases that may affect quality of life and radiation therapy)
  • Urinary retention, incontinens or IPPS score <12
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433797


Locations
Norway
Oslo Universuty Hospital, Radiumhospitalet and Aker
Oslo, Norway, 0310
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
Norwegian Cancer Society
The Research Council of Norway
Investigators
Principal Investigator: Wolfgang Lilleby, MD Rikshospitalet-Radiumhospitalet, Oslo
Principal Investigator: Sigbjørn Smeland, MD, PhD. Rikshospitalet-Radiumhospitalet, Oslo
  More Information

Responsible Party: Rune Blomhoff, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT00433797     History of Changes
Other Study ID Numbers: PFPI
S-06187 (REK Sør) ( Other Identifier: REK Sør )
2006-18 (RRHF) ( Other Identifier: Oslo University Hospital )
First Submitted: February 9, 2007
First Posted: February 12, 2007
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Rune Blomhoff, University of Oslo:
Prostate cancer
PSA
antioxidant
phytochemical
tomatoes
PUFA
selenium
soy
pomegranate
grapes

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases