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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433797
• Other study ID #: PFPI
• Secondary ID: S-06187 (REK Sør
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 9, 2007
• Last updated: December 18, 2013
• Start date: June 2007
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo Universuty Hospital, Radiumhospitalet and Aker	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
University of Oslo	Norwegian Cancer Society, Oslo University Hospital, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum prostate specific antigen		Baseline, after intervention, follow-up	No
Secondary	oxidative stress biomarkers in blood, tissue and urine		Baseline, after intervention, follow-up	No
Secondary	antioxidant status biomarkers in blood, tissue and urine		Baseline, after intervention, follow-up	No
Secondary	oxidative damage biomarkers in blood, tissue and urine		Baseline, after intervention, follow-up	No
Secondary	inflammation biomarkers in blood, tissue and urine		Baseline, after intervention, follow-up	No
Secondary	Apoptose markers in prostate tissue		Baseline, after intervention, follow-up	No
Secondary	DNA microarrays in blood cells and prostate tissue		Baseline, after intervention, follow-up	No