Recurrent Bladder CancerNCT01108003
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
A study testing broccoli sprout extract, laboratory biomarker analysis and Mango Juice in people with Recurrent Bladder Cancer and Stage 0 Bladder Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer
- What is being tested?
- broccoli sprout extract, laboratory biomarker analysis and Mango Juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient eligible for superficial bladder cancer
- Patients must be considered fit for surgical resection with curative intent
- No chemotherapy, surgery (excluding transurethral resection of bladder tumor [TURBT], BCG or radiotherapy in the prior 4 weeks [6 weeks for mitomycin C or interferon])
- No previous treatment/ingestion with broccoli extracts
- Eastern Oncology Group (ECOG) performance status 0-2
- AST and ALT =< 2.5 times ULN (upper limit of normal)
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- Total bilirubin =< 2.0 mg/dL
- Creatinine Clearance >= 30 ml/min
- WBC > 3000 mm^3
- Absolute neutrophil count > 1000/mm^3
- Platelets > 100,000/mm^3
- All patients must sign a study-specific consent form indicating that they are aware of the investigational nature of this study
Who cannot join
- Have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
- Prior radiation to the pelvis
- Intractable urinary tract infection that has not responded to antibiotic treatment
- Active, uncontrolled bacterial, viral, or fungal infection including HIV
- Have had major surgery within 4 weeks of starting therapy (not including placement of vascular access device or TURBT)
- Poor medical risk in the opinion of the treating oncologist due to non-malignant systemic disease
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- Pregnant or lactating patients: patients must be postmenopausal or practicing an accepted form of birth control; for patients where pregnancy is a possibility, a pregnancy test will be required prior to initiation of therapy
- Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 6 months (the patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months), or have uncontrolled congestive heart failure
- Have a history of bleeding disorders or thrombosis; patients on therapeutic doses of anticoagulation (including coumadin or heparins) are not permitted on trial (this exclusion criterion does not include those patients receiving low dose or prophylactic dose anticoagulation [i.e. coumadin 1 mg daily in patients with central intravenous lines])
- Radiotherapy during the course of the trial
- Inability to tolerate proposed treatment or procedures
- Have additional uncontrolled serious medical conditions or psychiatric illness
- Patients with a history of hepatitis (including but not exclusive to viral hepatitis auto-immune or alcoholic)
- Patients with active thyroid disease (patients with hypothyroidism, adequately replaced on a stable dose of thyroid replacement will be allowed on trial)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.
Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
Read the detailed description
Primary Objectives:
- To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.
Secondary Objectives:
- Establish the safety of administration of the broccoli extract on the bladder surgery specifically.
II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.
III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.
IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.
Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.
- Conditions
- Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Transitional Cell Carcinoma of the Bladder
- Being tested
- broccoli sprout extract, laboratory biomarker analysis, Mango Juice
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
broccoli sprout extractDrug
Given orally
laboratory biomarker analysisOther
Correlative studies
Mango JuiceOther
given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. Receives: Drug: broccoli sprout extract; Other: laboratory biomarker analysis |
| Arm 2 | Placebo comparator | Patients receive mango juice alone. Receives: Other: Mango Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
Number of participants with an adverse event.
Measured: 14 days
Secondary outcomes (1)
Apoptosis, Cell Proliferation, and Microvessel Density
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionOct 2015
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Bladder 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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James Marshall, PhD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108003
- Sponsor's protocol ID
- I 129408
- Other IDs
- NCI-2010-00759
- Status last verified
- May 2017
- First submitted
- 19 Apr 2010
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
- ClinicalTrials.gov ID
- NCT01108003
- Acronym / sponsor ID
- I 129408
- Conditions
- Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Transitional Cell Carcinoma of the Bladder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Cancer Institute (NCI)
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 23 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.
Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
Detailed description
Primary Objectives:
- To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.
Secondary Objectives:
- Establish the safety of administration of the broccoli extract on the bladder surgery specifically.
II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.
III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.
IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.
Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: broccoli sprout extract, Other: laboratory biomarker analysisPatients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. |
| Arm 2 | Placebo comparator | Other: Mango JuicePatients receive mango juice alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Any patient eligible for superficial bladder cancer
- Patients must be considered fit for surgical resection with curative intent
- No chemotherapy, surgery (excluding transurethral resection of bladder tumor [TURBT], BCG or radiotherapy in the prior 4 weeks [6 weeks for mitomycin C or interferon])
- No previous treatment/ingestion with broccoli extracts
- Eastern Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (14 listed)
- Have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
- Prior radiation to the pelvis
- Intractable urinary tract infection that has not responded to antibiotic treatment
- Active, uncontrolled bacterial, viral, or fungal infection including HIV
- Have had major surgery within 4 weeks of starting therapy (not including placement of vascular access device or TURBT)
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 |
|---|---|---|
| broccoli sprout extractGiven orally | Drug | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
| Mango Juicegiven orally | Other | Arm 2 |
Primary outcome
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
Time frame: 14 days
Number of participants with an adverse event.
1 secondary outcome
Apoptosis, Cell Proliferation, and Microvessel Density
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Marshall, PhD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing broccoli sprout extract, laboratory biomarker analysis and Mango Juice in people with Recurrent Bladder Cancer and Stage 0 Bladder Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0 (time frame: 14 days). 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 26 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.