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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00739791 |
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.
Condition | Intervention |
Prostate Cancer |
Procedure: exercise intervention Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: medical chart review Procedure: polymerase chain reaction Procedure: proteomic profiling Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration Procedure: reverse transcriptase-polymerase chain reaction Procedure: support group therapy Procedure: therapeutic dietary intervention |
MedlinePlus related topics: | Cancer Prostate Cancer |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Trial of Gene Expression Modulation by Intervention With Nutrition and Lifestyle |
Estimated Enrollment: | 34 |
Study Start Date: | September 2003 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
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).
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma (small cell acinar type) of the prostate
Prostate-specific antigen (PSA) ≤ 10.0 ng/mL (PSA < 15 ng/mL allowed for patients with benign prostatic hyperplasia or prostatitis)
Must have had 3 serum PSA levels performed ≥ 2 weeks apart over the past year to allow calculation of a PSA doubling time
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No prior or other concurrent treatment for prostate cancer, including any of the following:
UCSF Helen Diller Family Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Peter R. Carroll, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Responsible Party: | UCSF Helen Diller Family Comprehensive Cancer Center ( Peter R. Carroll ) |
Study ID Numbers: | CDR0000612335, UCSF-H5664-25348, UCSF CC#04553 |
First Received: | August 21, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00739791 |
Health Authority: | United States: Federal Government |
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