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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00607932
First received: February 1, 2008
Last updated: November 29, 2010
Last verified: November 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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
Indole-3-carbinol
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014