Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00739791
• Lead Sponsor: University of California, San Francisco

Brief Summary

RATIONALE: Learning about changes in DNA over time in patients with prostate cancer undergoing diet and lifestyle changes may help doctors learn about the long-term effects of these changes on disease progression.

PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with previously untreated stage I or stage II prostate cancer.

Detailed Description

OBJECTIVES:

* To measure changes in gene expression in prostate tissue core biopsy samples before and after a low-fat diet and lifestyle intervention in patients with previously untreated stage I or II adenocarcinoma of the prostate.

* To collect health information from these patients to enable better understanding of the long term impact of diet and lifestyle changes on prostate cancer progression.

OUTLINE:

* Intervention phase: Patients are placed on a comprehensive lifestyle change program comprising a low-fat vegan diet, stress management, moderate aerobic exercise, and regular participation in a support group for 3 months.

* Follow-up phase: Patients undergo core tissue biopsies at baseline and at 3 months for genomic and gene expression analysis. Insulin-like growth factor 1 (IGF-1) and selenium-binding protein 1 levels are measured by quantitative reverse transcription-polymerase chain reaction (PCR). Patients also undergo blood sample collection periodically for biomarker analysis, proteomic analysis, and for telomere length and telomerase activity analysis as measured by quantitative PCR and telomerase repeat amplification protocol (TRAP). Blood and urine samples are also collected and stored for future analysis.

Patients complete questionnaires at baseline, at 3 months, and then every 6-12 months for up to 3 years to assess dietary and lifestyle behaviors (exercise, stress management practice, and group support), quality of life, and psychological adjustment. Questionnaires include the Semi-Quantitative Food Frequency Questionnaire; the SF-36 Health Survey; the UCLA Prostate Cancer Index; the Impact of Event Scale; the Memorial Anxiety Scale for Prostate Cancer; the Post Traumatic Growth Inventory; the Mindful Attention Awareness Scale; and the Received Social Support subscale from the Berlin Social Support Scale.

Patients' medical records are reviewed every 6-12 months for up to 3 years to collect information on clinical events and biomarkers (e.g., prostate-specific antigen and Gleason score).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention

Secondary Outcome Measures

Name	Time	Method
Correlation of quality of life changes and adherence to dietary and lifestyle changes with gene expression outcomes
Telomere length and telomerase activity in blood samples in response to the dietary and lifestyle intervention as measured by quantitative polymerase chain reaction and telomerase repeat amplification protocol (TRAP)