Clinical trial · Interventional
Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
NCT01108003CI-TRIAL-00028270terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage 0 Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Transitional Cell Carcinoma of the Bladder | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| broccoli sprout extract | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| Mango Juice | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: broccoli sprout extract
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Patients receive mango juice alone.
- interventionNames
- Other: Mango Juice
Primary outcomes (1)
- measure
- Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.