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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.
- 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.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
behavioral dietary intervention, Brassica vegetable, indole-3-carbinol, counseling intervention, medical chart review, questionnaire administration, adjuvant therapy
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:33:15-0400
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Proteins which are present in or isolated from vegetables or vegetable products used as food. The concept is distinguished from PLANT PROTEINS which refers to non-dietary proteins from plants.
A plant genus of the family Cruciferae. It contains many species and cultivars used as food including cabbage, cauliflower, broccoli, Brussel sprouts, kale, collard greens, MUSTARD PLANT; (B. alba, B. junica, and B. nigra), turnips (BRASSICA NAPUS) and rapeseed (BRASSICA RAPA).
Counseling during which a professional plays an active role in a client's or patient's decision making by offering advice, guidance, and/or recommendations.
Counseling conducted via electronic or other non-face-to-face interactions.
Any of several BRASSICA species that are commonly called mustard. Brassica alba is white mustard, B. juncea is brown or Chinese mustard, and B. nigra is black, brown, or red mustard. The plant is grown both for mustard seed from which oil is extracted and for greens or animal feed. It was formerly used as an emetic, counter-irritant, and carminative. There is no relationship to MUSTARD COMPOUNDS.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...