Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer
NCT ID: NCT00739791
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2003-09-30
2005-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This clinical trial is studying nutrition and lifestyle changes in patients with previously untreated stage I or stage II prostate cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
exercise intervention
gene expression analysis
polymerase chain reaction
proteomic profiling
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
medical chart review
questionnaire administration
psychosocial assessment and care
quality-of-life assessment
support group therapy
therapeutic dietary intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed adenocarcinoma (small cell acinar type) of the prostate
* Has undergone an extended pattern biopsy (defined as 8+ cores) within the past 2 years OR is scheduled to undergo an extended pattern clinical biopsy within 6 weeks of starting study intervention and is willing to undergo 4 additional research core biopsies
* No more than 33% of biopsy cores positive (\> 33% of biopsy cores positive allowed if due to microfoci of adenocarcinoma)
* No more than 50% of the length of a tumor core involved by carcinoma
* Clinical stage T1 or T2a disease
* Previously untreated disease
* Gleason score ≤ 6 with no pattern 4 or 5 histology (Gleason pattern 4 seen as a microfocus \[\< 2 mm in length\] allowed)
* 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
* No PSA doubling time of \< 3 months
* Has chosen watchful waiting as treatment
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Living in the greater San Francisco Bay Area
* Willing to make comprehensive lifestyle changes
* Baseline dietary fat intake ≥ 15%
* Able to participate in the exercise portion of this study, as determined by the cardiologist or primary care physician
* No limited exercise tolerance precluding participation in the lifestyle intervention component of this study
* No comprehensive lifestyle change similar to the lifestyle intervention used in this study
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Coronary artery disease requiring a revascularization procedure
* Cardiac arrhythmia
* Psychiatric illness/social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
* No prior or other concurrent treatment for prostate cancer, including any of the following:
* Surgery
* Radiotherapy
* Hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin, megestrol acetate, nilutamide, or DES/estrogen)
* Chemotherapy
* PC-SPES
* Investigational agents
* More than 4 weeks since prior and no concurrent finasteride or dutasteride
* More than 4 weeks since prior and no concurrent saw palmetto or any other herbal/nutritional preparation that would affect hormone levels
* More than 4 weeks since prior multivitamin/mineral and/or supplemental soy protein, vitamin E, vitamin C, selenium, fish oil, or any other preparation intended to supplement levels of omega-3 unsaturated fatty acids
* More than 1 month since prior and no concurrent NSAIDs, COX-2-inhibitors, and/or aspirin used for \> 7 consecutive days
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
UCSF Helen Diller Family Comprehensive Cancer Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter R. Carroll, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1016/S1470-2045(08)70234-1. Epub 2008 Sep 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCSF-H5664-25348
Identifier Type: -
Identifier Source: secondary_id
UCSF CC#04553
Identifier Type: -
Identifier Source: secondary_id
CDR0000612335
Identifier Type: -
Identifier Source: org_study_id