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

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ClinicalTrials.gov Identifier: NCT00739791
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 21, 2008
First Posted Date  ICMJE August 22, 2008
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE September 2003
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
Changes in gene expression in prostate tissue core biopsy samples as measured before and after a low-fat diet and lifestyle intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutrition and Lifestyle Changes in Patients With Previously Untreated Stage I or Stage II Prostate Cancer
Official Title  ICMJE 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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Behavioral: exercise intervention
  • Genetic: gene expression analysis
  • Genetic: polymerase chain reaction
  • Genetic: proteomic profiling
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
  • Procedure: support group therapy
  • Procedure: therapeutic dietary intervention
Study Arms  ICMJE Not Provided
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. doi: 10.1016/S1470-2045(08)70234-1. Epub 2008 Sep 15. Erratum in: Lancet Oncol. 2008 Dec;9(12):1124.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 21, 2008)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00739791
Other Study ID Numbers  ICMJE CDR0000612335
UCSF-H5664-25348
UCSF CC#04553
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter R. Carroll, UCSF Helen Diller Family Comprehensive Cancer Center
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Peter R. Carroll, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP