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

December 18, 2013 updated by: Rune Blomhoff, University of Oslo

Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0310
        • Oslo Universuty Hospital, Radiumhospitalet and Aker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • PFPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum prostate specific antigen
Time Frame: Baseline, after intervention, follow-up
Baseline, after intervention, follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Oslo University Hospital
The Research Council of Norway
Norwegian Cancer Society

Investigators

  • Principal Investigator: Wolfgang Lilleby, MD, Rikshospitalet-Radiumhospitalet, Oslo
  • Principal Investigator: Sigbjørn Smeland, MD, PhD., Rikshospitalet-Radiumhospitalet, Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFPI
  • S-06187 (REK Sør) (Other Identifier: REK Sør)
  • 2006-18 (RRHF) (Other Identifier: Oslo University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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