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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00607932
First received: February 1, 2008
Last updated: November 29, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention ] [ Designated as safety issue: Yes ]
  • Effects of intervention on prostate-specific antigen [ Time Frame: Not noted ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: March 2005
Study Completion Date: November 2010
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brassica Vegetables Diet Intervention Behavioral: behavioral dietary intervention
Not specified
Other Name: behavioral dietary intervention
Dietary Supplement: Brassica vegetable
Not specified
Other Name: 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 Name: counseling intervention
Other: medical chart review
2,4,6 months post baseline
Other Name: medical chart review
Other: questionnaire administration
not specified
Other Name: questionnaire administration
Procedure: adjuvant therapy
not specified
Other Name: adjuvant therapy
Experimental: Pill 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 Name: counseling intervention
Other: medical chart review
2,4,6 months post baseline
Other Name: medical chart review
Other: questionnaire administration
not specified
Other Name: questionnaire administration
Procedure: adjuvant therapy
not specified
Other Name: adjuvant therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607932

Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Jay H. Fowke, PhD, MPH Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jay Fowke, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00607932     History of Changes
Other Study ID Numbers: CDR0000581410, VU-VICC-URO-0369, VU-VICC-041001
Study First Received: February 1, 2008
Last Updated: November 29, 2010
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
 Adjuvants, Immunologic
Indole-3-carbinol
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013