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

University of Oslo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Dietary Supplement: Prostate cancer, phytochemical and PUFA

Study type: Interventional

Funder types: Other

Identifiers

NCT00433797

PFPI

2006-18 (RRHF) (Other Identifier)

S-06187 (REK Sør) (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

86 participants in 3 patient groups

1

Experimental group

Description:

Tomato

Treatment:

Dietary Supplement: Prostate cancer, phytochemical and PUFA

2

Experimental group

Description:

Multi-diet

Treatment:

Dietary Supplement: Prostate cancer, phytochemical and PUFA

3

Active Comparator group

Description:

Control

Treatment:

Dietary Supplement: Prostate cancer, phytochemical and PUFA