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Tracking Information | |||||
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First Received Date † | August 21, 2008 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | September 2003 | ||||
Current Primary Outcome Measures † |
Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00739791 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer | ||||
Official Title † | Pilot Trial of Gene Expression Modulation by Intervention With Nutrition and Lifestyle | ||||
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. |
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Detailed Description | OBJECTIVES:
OUTLINE:
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). |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment | ||||
Condition † | Prostate Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | Ornish D, Lin J, Daubenmier J, Weidner G, Epel E, Kemp C, Magbanua MJ, Marlin R, Yglecias L, Carroll PR, Blackburn EH. Increased telomerase activity and comprehensive lifestyle changes: a pilot study. Lancet Oncol. 2008 Nov;9(11):1048-57. Epub 2008 Sep 15. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 34 | ||||
Completion Date | |||||
Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Male | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00739791 | ||||
Responsible Party | Peter R. Carroll, UCSF Helen Diller Family Comprehensive Cancer Center | ||||
Secondary IDs †† | UCSF-H5664-25348, UCSF CC#04553 | ||||
Study Sponsor † | UCSF Helen Diller Family Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |