Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients - Full Text View

Sponsors and Collaborators:	University of Oslo Rikshospitalet HF Norwegian Cancer Society The Research Council of Norway
Information provided by:	University of Oslo
ClinicalTrials.gov Identifier:	NCT00433797

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Cancer Diets Prostate Cancer Urine and Urination

U.S. FDA Resources

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 ]

Estimated Enrollment:	102
Study Start Date:	June 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Active Comparator 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433797

Contacts

Contact: Rune Blomhoff, PhD	+47-22851395	rune.blomhoff@medisin.uio.no
Contact: Anette Karlsen, MS	+47-22851524	anette.karlsen@medisin.uio.no

Locations

Norway
Rikshospitalet-Radiumhospitalet HF	Recruiting
Oslo, Norway, 0310
Contact: Wolfgang Lilleby, Dr Med +4722934000
Contact: Guro Lindviksmoen, Study Nurse +4722934000

Sponsors and Collaborators

University of Oslo

Rikshospitalet HF

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:	University of Oslo ( Professor Rune Blomhoff )
Study ID Numbers:	PFPI, S-06187 (REK Sør), 2006-18 (RRHF)
Study First Received:	February 9, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00433797 History of Changes
Health Authority:	Norway: Directorate for Health and Social Affairs; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: The National Committees for Research Ethics in Norway

Keywords provided by University of Oslo:

Prostate cancer
PSA
antioxidant
phytochemical
tomatoes

PUFA
selenium
soy
pomegranate
grapes

Study placed in the following topic categories:

Selenium
Antioxidants
Pomegranate
Prostatic Diseases
Genital Neoplasms, Male
Tea

Urogenital Neoplasms
Tomato
Genital Diseases, Male
Grape
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009