Broccoli, Peas and PIN

Prostatic Intraepithelial Neoplasia Clinical Trial

Official title:

A Human Intervention Trial Studying Gene Expression in High-Grade Prostatic Intraepithelial Neoplasia Following Consumption of Broccoli or Peas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535977
• Other study ID #: IFR07-2004
• Secondary ID: 05/Q0101/92004IF
• Status: Completed
• Phase: N/A
• First received: September 26, 2007
• Last updated: September 26, 2007
• Start date: April 2005
• Est. completion date: April 2007

Study information

• Verified date: September 2007
• Source: Institute of Food Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norwich Research Ethics Committee UK:
• Study type: Interventional

Clinical Trial Summary

This is a parallel human intervention trial to determine to what extent a dietary intervention of broccoli or peas can change the expression (switching on or off) of genes in prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).

Description:

Cancer is one of the main causes of death among humans in the world. Prostate cancer affects 20,000 men in the UK alone each year. Diet is known to be a major factor that influences risk of cancer. Therefore, changes to the diet may alter cancer risk. Cruciferous vegetables, particularly broccoli, provide the diet with a substantial source of plant chemicals called glucosinolates. Previous research has indicated that glucosinolates break down to form isothiocyanates (ITCs) that can be absorbed in the body. Further research has indicated that ITCs may protect the body against the development of prostate cancer. However, the mechanisms behind this effect are not fully understood.

ITCs are thought to be powerful anti cancer agents as they can modulate the expression (switching on or off) of specific genes involved in the removal of toxic substances such as carcinogens from the body. In this study we wish to evaluate the effect of consumption of a conventionally bred cultivar of broccoli containing high levels of ITCs on gene expression in prostate tissue to gain a better understanding of its mechanism of action. Several studies suggest a further protection against cancer amongst individuals who have a deletion of certain genes.

This pilot study comprises a 12-month intervention of either 400g ITC-enriched broccoli per week of 400g garden peas in men at high risk of developing prostate cancer. Changes in gene expression of prostate biopsy tissue will be compared before and after 6 and 12 months of intervention in both dietary groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Men with a previous diagnosis of high-grade Prostatic Intraepithelial Neoplasia

• BMI >18.5 or <35

• Aged between 30-70 years

Exclusion Criteria:

• Undergoing chemopreventive therapy

• Receiving testosterone replacement medicines

• Active infection requiring treatment

• BMI <18.5 or >35

• Diagnosed with diabetes

• Unable to give informed consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carcinoma in Situ
• Neoplasms
• Prostatic Intraepithelial Neoplasia

Intervention

Dietary Supplement:
• Broccoli
400g ITC-enriched broccoli per week for 12 months
• Peas
400g frozen garden peas per week for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Food Research

References & Publications (10)

Chiao JW, Chung FL, Kancherla R, Ahmed T, Mittelman A, Conaway CC. Sulforaphane and its metabolite mediate growth arrest and apoptosis in human prostate cancer cells. Int J Oncol. 2002 Mar;20(3):631-6. — View Citation

Cotton SC, Sharp L, Little J, Brockton N. Glutathione S-transferase polymorphisms and colorectal cancer: a HuGE review. Am J Epidemiol. 2000 Jan 1;151(1):7-32. Review. — View Citation

Fenwick GR, Heaney RK, Mullin WJ. Glucosinolates and their breakdown products in food and food plants. Crit Rev Food Sci Nutr. 1983;18(2):123-201. Review. — View Citation

Gamet-Payrastre L, Li P, Lumeau S, Cassar G, Dupont MA, Chevolleau S, Gasc N, Tulliez J, Tercé F. Sulforaphane, a naturally occurring isothiocyanate, induces cell cycle arrest and apoptosis in HT29 human colon cancer cells. Cancer Res. 2000 Mar 1;60(5):1426-33. — View Citation

Giovannucci E, Rimm EB, Liu Y, Stampfer MJ, Willett WC. A prospective study of cruciferous vegetables and prostate cancer. Cancer Epidemiol Biomarkers Prev. 2003 Dec;12(12):1403-9. — View Citation

Hecht SS. Inhibition of carcinogenesis by isothiocyanates. Drug Metab Rev. 2000 Aug-Nov;32(3-4):395-411. Review. — View Citation

Hintze KJ, Keck AS, Finley JW, Jeffery EH. Induction of hepatic thioredoxin reductase activity by sulforaphane, both in Hepa1c1c7 cells and in male Fisher 344 rats. J Nutr Biochem. 2003 Mar;14(3):173-179. — View Citation

Key TJ, Silcocks PB, Davey GK, Appleby PN, Bishop DT. A case-control study of diet and prostate cancer. Br J Cancer. 1997;76(5):678-87. — View Citation

Mithen R, Faulkner K, Magrath R, Rose P, Williamson G, Marquez J. Development of isothiocyanate-enriched broccoli, and its enhanced ability to induce phase 2 detoxification enzymes in mammalian cells. Theor Appl Genet. 2003 Feb;106(4):727-34. Epub 2002 Oct 24. — View Citation

Surh YJ. Cancer chemoprevention with dietary phytochemicals. Nat Rev Cancer. 2003 Oct;3(10):768-80. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gene expression in RNA extracted from prostate tissue		Baseline, 6 months and 12 months
Secondary	Changes in levels of serum prostate specific antigen (PSA)		Baseline, 6 months and 12 months