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Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00607932
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jay Fowke, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE February 1, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE March 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2010)
  • Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation [ Time Frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention ]
  • Adverse events [ Time Frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention ]
  • Effects of intervention on prostate-specific antigen [ Time Frame: Not noted ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2008)
  • Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
  • Adverse events
  • Effects of intervention on PSA
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
Official Title  ICMJE Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
Brief Summary

RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence.

PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.

Detailed Description

OBJECTIVES:

  • Determine the feasibility of Brassica vegetable intake and indole-3-carbinol supplement use in patients with prostate cancer with prostate-specific antigen (PSA) recurrence after prostatectomy.
  • Identify adverse events in these patients.
  • Quantify the effects of each intervention on PSA in these patients.

OUTLINE: Patients are stratified by pretreatment prostat-specific antigen (PSA) growth rate (low [0.00-0.15] vs medium [0.16-0.30] vs high [> 0.30]). They are randomized to 1 of 3 treatment arms, and randomization status to arms II and III is double-blinded.

  • Arm I (Brassica vegetables): Patients consume Brassica vegetables at least 2 servings (½ cup/serving) daily for 6 months. Patients meet one-on-one with the study dietician, and are instructed on the potential health benefits of Brassica vegetables and purchase and preparation of the vegetables. Patients undergo telephone counseling periodically in months 1-5, to monitor their progress and identify barriers to adherence and to develop solutions to overcome these barriers.
  • Arm II (Placebo): Patients receive oral placebo once daily for 6 months.
  • Arm III (Indole-3-carbinol supplement): Patients receive oral indole-3-carbinol supplement (capsules) once daily for 6 months.

Blood and urine samples (for urinary isothiocyanate levels) are collected at baseline and at 2, 4, and 6 months. Patients complete questionnaires assessing demographics, family cancer history, and health history and measuring changes in medications, lifestyle, adverse events, and health. Medical records are reviewed for prostate cancer-related information, surgical dates, dose and type of radiation, and PSA history.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Behavioral: behavioral dietary intervention
  • Dietary Supplement: Brassica vegetable
  • Drug: indole-3-carbinol
    follow up at 2,4,6 months post baseline.
    Other Name: I3C
  • Other: counseling intervention
    2, 4, 6 months post baseline
  • Other: medical chart review
    2,4,6 months post baseline
  • Other: questionnaire administration
  • Procedure: adjuvant therapy
Study Arms  ICMJE
  • Experimental: Brassica Vegetables Diet Intervention
    Interventions:
    • Behavioral: behavioral dietary intervention
    • Dietary Supplement: Brassica vegetable
    • Drug: indole-3-carbinol
    • Other: counseling intervention
    • Other: medical chart review
    • Other: questionnaire administration
    • Procedure: adjuvant therapy
  • Experimental: Pill
    Interventions:
    • Drug: indole-3-carbinol
    • Other: counseling intervention
    • Other: medical chart review
    • Other: questionnaire administration
    • Procedure: adjuvant therapy
Publications * Not Provided

*   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: February 2, 2008)
66
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of prostate cancer with PSA recurrence after prostatectomy

    • PSA recurrence is defined as two consecutively rising PSA tests ≥ 8 weeks since the post-surgical nadir, with a minimal interval of 2 weeks between tests and at least 1 PSA test > 0.4 ng/mL

Exclusion Criteria:

  • Life expectancy ≥ 9 months
  • No predictors of poor adherence (e.g., erratic life-style, mental incompetence)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No other concurrent Brassica vegetable consumption > 1 serving/day
  • No other concurrent indole-3-carbinol supplements
  • No endocrine or radiation treatment within past 4 weeks
  • No other scheduled treatment during study intervention
  • Concurrent prescription medications during the trial allowed

    • At least 2 weeks since prior and no concurrent vitamin or herbal supplement use

      • Patients refusing to stop non-study supplements will be asked to maintain constant use
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (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 NCT00607932
Other Study ID Numbers  ICMJE CDR0000581410
VU-VICC-URO-0369
VU-VICC-041001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jay Fowke, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jay H. Fowke, PhD, MPH Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt University
Verification Date April 2016

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