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

This study has been completed.
Sponsor:
Collaborators:
Oslo University Hospital
Norwegian Cancer Society
The Research Council of Norway
Information provided by (Responsible Party):
Rune Blomhoff, University of Oslo
ClinicalTrials.gov Identifier:
NCT00433797
First received: February 9, 2007
Last updated: December 18, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 University of Oslo:

Primary Outcome Measures:
  • serum prostate specific antigen [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • oxidative stress biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]
  • antioxidant status biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]
  • oxidative damage biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]
  • inflammation biomarkers in blood, tissue and urine [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]
  • Apoptose markers in prostate tissue [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]
  • DNA microarrays in blood cells and prostate tissue [ Time Frame: Baseline, after intervention, follow-up ] [ Designated as safety issue: No ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rune Blomhoff, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT00433797     History of Changes
Other Study ID Numbers: PFPI, S-06187 (REK Sør), 2006-18 (RRHF)
Study First Received: February 9, 2007
Last Updated: December 18, 2013
Health Authority: Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on September 22, 2014