Prostate CancerNCT00607932
Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
A study testing behavioral dietary intervention, Brassica vegetable and indole-3-carbinol in people with Prostate Cancer, run by Vanderbilt University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- behavioral dietary intervention, Brassica vegetable and indole-3-carbinol
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- behavioral dietary intervention, Brassica vegetable, indole-3-carbinol, counseling intervention, medical chart review
- Keywords
- recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
Brassica vegetableDietary supplement
indole-3-carbinolDrug
Also called I3C
follow up at 2,4,6 months post baseline.
counseling interventionOther
2, 4, 6 months post baseline
medical chart reviewOther
2,4,6 months post baseline
questionnaire administrationOther
adjuvant therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Brassica Vegetables Diet Intervention | Experimental | Not described Receives: 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 |
| Pill | Experimental | Not described Receives: Drug: indole-3-carbinol; Other: counseling intervention; Other: medical chart review; Other: questionnaire administration; Procedure: adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
Measured: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Adverse events
Measured: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Effects of intervention on prostate-specific antigen
Measured: Not noted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMar 2005
- Primary completionJan 2007
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jay Fowke, Vanderbilt University
- Investigators
- Jay H. Fowke, PhD, MPH, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607932
- Sponsor's protocol ID
- CDR0000581410
- Other IDs
- VU-VICC-URO-0369, VU-VICC-041001
- Status last verified
- Apr 2016
- First submitted
- 1 Feb 2008
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
- ClinicalTrials.gov ID
- NCT00607932
- Acronym / sponsor ID
- CDR0000581410
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brassica Vegetables Diet Intervention | Experimental | 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 |
| Pill | Experimental | Drug: indole-3-carbinol, Other: counseling intervention, Other: medical chart review, Other: questionnaire administration, Procedure: adjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of prostate cancer with PSA recurrence after prostatectomy
Key exclusion criteria (11 listed)
- Life expectancy ≥ 9 months
- No predictors of poor adherence (e.g., erratic life-style, mental incompetence)
- See Disease Characteristics
- No other concurrent Brassica vegetable consumption > 1 serving/day
- No other concurrent indole-3-carbinol supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral dietary intervention | Behavioural | Brassica Vegetables Diet Intervention |
| Brassica vegetable | Dietary supplement | Brassica Vegetables Diet Intervention |
| indole-3-carbinolAlso: I3Cfollow up at 2,4,6 months post baseline. | Drug | Brassica Vegetables Diet Intervention, Pill |
| counseling intervention2, 4, 6 months post baseline | Other | Brassica Vegetables Diet Intervention, Pill |
| medical chart review2,4,6 months post baseline | Other | Brassica Vegetables Diet Intervention, Pill |
| questionnaire administration | Other | Brassica Vegetables Diet Intervention, Pill |
| adjuvant therapy | Procedure or surgery | Brassica Vegetables Diet Intervention, Pill |
Primary outcome
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
Adverse events
Time frame: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Effects of intervention on prostate-specific antigen
Time frame: Not noted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay H. Fowke, PhD, MPH study chair
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, Brassica vegetable and indole-3-carbinol in people with Prostate Cancer, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.