Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 03/31/2016 |
| Първо изпратено: | 01/31/2008 |
| Очаквано записване подадено: | 02/01/2008 |
| Първо публикувано: | 02/05/2008 |
| Изпратена последна актуализация: | 04/25/2016 |
| Последна актуализация публикувана: | 04/26/2016 |
| Действителна начална дата на проучването: | 02/28/2005 |
| Приблизителна дата на първично завършване: | 12/31/2006 |
| Очаквана дата на завършване на проучването: | 10/31/2010 |
Състояние или заболяване
Интервенция / лечение
Behavioral: Brassica Vegetables Diet Intervention
Dietary Supplement: Brassica Vegetables Diet Intervention
Drug: indole-3-carbinol
Other: counseling intervention
Other: medical chart review
Other: questionnaire administration
Procedure: adjuvant therapy
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Brassica Vegetables Diet Intervention | Behavioral: Brassica Vegetables Diet Intervention |
| Experimental: Pill |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. 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]
2. Adverse events [will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention]
3. Effects of intervention on prostate-specific antigen [Not noted]
