Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
- Determine the feasibility of Brassica vegetable intake and indole-3-carbinol supplement
use in patients with prostate cancer with prostate-specific antigen (PSA) recurrence
- 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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Jay H. Fowke, PhD, MPH
Vanderbilt-Ingram Cancer Center
United States: Federal Government